!
!
!
!
!
Ministry(of(Health(Malaysia!
NATIONAL(MOH(COCHLEAR(IMPLANT(PROGRAMME(
5<YEAR(REPORT:(2009<2013!
(
Advisor(
Datin!Dr!Siti!Sabzah!binti!Mohd!Hashim!
!
Editors((
Dr!Zulkiflee!bin!Salahudin!
Dr!Philip!Rajan!
!
Co<Editors:!
!
Mas!Diana!binti!Samsudin!
Nur!Azyani!binti!Amri!
Farah!Dalila!binti!Mohamed!Tahir!
Azmawanie!binti!Ab!Aziz!
Noormala!binti!Anuar!Ali!
Norhana!binti!Abu!Seman@Talib!
!
!
January!2016!
Medical!Development!Division,!Ministry!of!Health!Malaysia
Jointly!published!by:
National!ORL!Registry!–!Hearing!and!Otology!Related!Disease/Cochlear!Implant!and!Clinical!Research!
Centre!(CRC)
Contact:
!
Dr!Patimah!binti!Amin!
Head!!
Surgical!&!Emergency!Unit!(Cochlear!Implant!Programme)!
Medical!Development!Division!!
Ministry!of!Health!Malaysia!
!
Tel:!+603S88831159
Fax:!+603S88831155!
Email:!patimah_amin@moh.gov.my!
!
Or!
!
National!ORL!Registry!–!Hearing!and!Otology!Related!Disease/Cochlear!Implant!
Registry!Coordinating!Centre
c/o!Clinical!Research!Centre!
Hospital!Sultanah!Bahiyah!
KM!6,!Jalan!Langgar
05460!Alor!Setar,!Kedah!
Malaysia!
Tel:!+604S740!6229
Fax:!+604S740!7373!
Email:!orlregistry@gmail.com!!
Website:!https://app.acrm.org.my/ORL!
Disclaimer
Data! reported! was! acquired! from! the! National! ORL! Registry! –! Hearing! and! Otology! Related!
Disease/Cochlear! Implant! &! data! source! providers! (MOH! facilities).! Interpretation! and! reporting! is!
the!responsibility!of!the!editors!and!do!not!reflect!the!official!policy!of!the!publisher!or!the!authors’!
affiliated!institutions.!Caution!is!advised!before!drawing!conclusions!from!the!data.
This! report! is! copyrighted.! Reproduction! and! dissemination! of! this! report! in! part! or! in! whole! for!
research,! educational! or! other! nonScommercial! purpose! are! allowed! with! prior! written! permission!
from!the!copyright!holders!provided!the!source!is!fully!acknowledged.
The!electronic!version!of!this!report!can!be!viewed!at!www.moh.gov.my1
TABLE(OF(CONTENTS(
ACKNOWLEDGEMENT(.....................................................................................................................(i(
FOREWORD(......................................................................................................................................(ii(
MEDICAL(WRITING(COMMITTEE(............................................................................................(vii(
PARTICIPATING(CLINICAL(SITES((SOURCE(DATA(PROVIDER)(.......................................(ix(
ABBREVIATIONS(............................................................................................................................(xi(
GLOSSARY(.......................................................................................................................................(xii(
LIST(OF(TABLES(AND(FIGURES(................................................................................................(xiv(
CHAPTER(1:(INTRODUCTION(.....................................................................................................(1(
CHAPTER(2:(OBJECTIVE(...............................................................................................................(5(
CHAPTER(3:(METHODOLOGY(.....................................................................................................(7(
a.! Data!Collection!...........................................................................................................................................................!8!
b.! Measuring!Level!Of!Outcomes!.............................................................................................................................!8!
1.! Surgical+Complications+............................................................................................................................................+8!
2.! Aided+Thresholds+........................................................................................................................................................+9!
3.! Auditory+Perception+..................................................................................................................................................+9!
4.! Speech+Production+.....................................................................................................................................................+9!
5.! Timing+of+First+Word+Production+.....................................................................................................................+11!
c.! Factors!Affecting!Outcomes!................................................................................................................................!11!
d.! Statistical!Analysis!..................................................................................................................................................!12!
++++1.+++++Prelingual!...............................................................................................................................................................!12!
2.! Postlingual+&+CrossDOver+Group+.......................................................................................................................+13!
e.! Limitation!Of!The!Study!.......................................................................................................................................!13!
CHAPTER(4:(RESULTS(.................................................................................................................(14(
Demographic!Data!...........................................................................................................................................................!15!
a.! Prelingual!Group!.....................................................................................................................................................!15!
1.! Surgical+Complications+.........................................................................................................................................+18!
2.! Aided+Threshold+.......................................................................................................................................................+19!
3.! Categorical+Auditory+Performances+(CAP)+Score+.....................................................................................+19!
4.! Speech+Intelligibility+Rating+Scale+(SIR)+.......................................................................................................+22!
5.! First+Word+Production+..........................................................................................................................................+24!
6.! Factors+Affecting+Outcomes:+..............................................................................................................................+25!
b.! Post!Lingual!And!CrossPOver!Group!...............................................................................................................!28!
1.! Surgical+complications+.........................................................................................................................................+28!
2.! Aided+threshold+........................................................................................................................................................+29!
3.! Categorical+Auditory+Performances+(CAP)+test+.........................................................................................+29!
CHAPTER(5:(DISCUSSION(...........................................................................................................(32(
Age!Of!Diagnosis!And!Implantation!In!Prelingual!Patients!...........................................................................!33!
Surgical!Outcomes!...........................................................................................................................................................!33!
Functional!Outcomes!......................................................................................................................................................!34!
CHAPTER(6:(SUMMARY(&(RECOMMENDATIONS(................................................................(36(
Summary!..............................................................................................................................................................................!37!
Recommendations!...........................................................................................................................................................!38!
Plan!Of!Action!....................................................................................................................................................................!39!
REFERENCES:(.................................................................................................................................(40(
ACKNOWLEDGEMENT(
!
The!National!MOH!Cochlear!Implant!Programme!and!National!ORL!Registry!would!
like!to!express!its!gratitude!and!appreciation!to!everyone!who!has!helped!make!this!
report!possible.!!
!!
We!would!especially!like!to!thank!the!following:!
!
Our!source!data!providers,!for!hard!work,!timely!data!collection!and!submission;!!
!
•
Hospital!Sultanah!Bahiyah,!Alor!Setar!
•
Hospital!Raja!Permaisuri!Bainun,!Ipoh!
•
Hospital!Raja!Perempuan!Zainab!II,!Kota!Bharu!
•
Hospital!Sultanah!Nur!Zahirah,!Kuala!Terengganu!
•
Hospital!Kuala!Lumpur!
•
Hospital!Sungai!Buloh,!Selangor!
•
Hospital!Tuanku!Jaafar,!Seremban!
•
Hospital!Sultan!Ismail,!Johor!Bharu!
Hospital!Queen!Elizabeth,!Kota!Kinabalu!
!
DirectorPGeneral!of!Health!and!Director!of!Medical!Development!Division,!Ministry!of!
Health!Malaysia!for!their!support!of!the!registry!and!approval!to!publish!this!report.!
!
Clinical! Research! Centre,! Hospital! Sultanah! Bahiyah,! Alor! Setar! for! its! continuing!
support,!guidance!and!technical!support.!!
!
To!all!our!programme!advisors,!of!Universiti!Kebangsaan!Malaysia,!Universiti!Sains!
Malaysia!and!Universiti!Malaya.!!
!
Members!of!the!medical!writing!committee!and!participating!clinical!sites!for!their!
tireless!effort!and!commitment!to!the!program.!
!
•
National MOH CI Programme: 5-Year Report 2009-2013|ms
i!
( (
(
(
Foreword'!
By!the!Director,General!of!Health!Malaysia!
(
!
The!Ministry!of!Health!Cochlear!Implant!team!was!formed!in!2008!with!the!aim!to!start!
a! cochlear! implant! programme! within! the! framework! of! the! Ministry! of! Health.! While!
the! local! universities! provided! existing! services,! there! was! a! need! to! reach! out! to!
citizens!who!might!benefit!from!a!cochlear!implant,!particularly!deaf!children!for!whom!
this! technology! could! confer! hearing! and! profoundly! alter! their! course! of! life.! The!
infrastructure!of!the!Ministry!of!Health,!Malaysia!with!healthcare!facilities!in!every!part!
of!Malaysia,!provided!an!ideal!vehicle!for!a!nationwide!outreach.!!
The!implementation!of!the!programme!was!a!huge!undertaking!with!considerable!cost!
implications.!Staff!had!to!be!trained;!surgeons,!audiologists,!speech!therapists!as!well!as!
other!medical!staff.!Equipment!had!to!be!procured;!microscopes,!facial!nerve!monitors,!
surgical!drills,!mastoid!instruments;!to!name!a!few.!An!annual!allocation!of!about!RM5!
million!was!allocated!for!implants!alone.!!
Today,! the! programme! is! firmly! established! and! now! well! into! its! eighth! year.! In! the!
first!five!years,!184!Malaysian!citizens!benefitted!from!the!programme.!The!results!and!
outcomes!are!given!in!detail!in!this!document.!I!am!well!pleased!with!the!results,!with!
the! majority! of! the! recipients! benefitting! from! the! implant.! The! success! of! the!
programme!comes!as!no!surprise!to!me.!Meticulous!and!detailed!planning!by!the!ORL!
fraternity!and!Medical!Development!Division!took!place!well!before!the!first!implant!to!
ensure!a!smooth!and!seamless!implementation!of!the!programme.!
This!success!would!not!have!been!possible!without!the!support!from!our!advisors!from!
the! local! universities! who! have! obliged! to! share! their! experience! with! us.! I! am! deeply!
appreciative!of!their!guidance!and!their!generosity!with!their!time!and!knowledge.!
!
National MOH CI Programme: 5-Year Report 2009-2013|ms
ii!
!
I!am!confident!the!second!five!years!of!the!programme!will!see!further!progress!with!a!
more! seasoned! and! experienced! team.! This! review,! the! first! of! its! kind! in! Malaysia,!
offers! a! comprehensive! review! of! a! national! cochlear! implant! programme,! which! is! a!
reflection! of! the! programme’s! maturity.! I! congratulate! the! ORL! fraternity! for! this!
success!and!look!forward!to!a!‘deafPfree’!Malaysian!society.!
(
(
(
(
(
Datuk(Dr(Noor(Hisham(bin(Abdullah(
Director<General(of(Health(Malaysia(
National MOH CI Programme: 5-Year Report 2009-2013|ms
iii!
!
!
!
!
!
Foreword!!
By!the!Director!of!Medical!Development!Division!
!
WHO! has! defined! Hearing! Impairment! as! one! of! the! major! public! health! and! social!
problems! and! over! 250! millions! people! are! estimated! to! suffer! from! hearing!
impairment.!With!the!current!advancement!of!medical!technology!,!the!disability!from!
the!hearing!impairment!can!be!reduced.!
Cochlear! implant! has! been! accepted! worldwide! as! one! of! the! treatment! of! hearing!
impaired! patient! who! has! no! benefit! from! hearing! aid.! It! is! a! surgically! implanted!
electronic! device! that! provides! sense! of! sound! to! a! person! who! is! profoundly! deaf! or!
severely!hard!of!hearing.!Approximately!324,000!people!worldwide!have!received!the!
device!with!recipients!including!both!adults!and!children.!
Considerable! time,! effort! and! costs! were! involved! in! setting! up! the! Ministry! of! Health!
Cochlear! Implant! Programme! in! 2008.! The! good! relationship! between! the! ORL!
fraternity! and! Medical! Development! Division! has! enabled! smooth! and! rapid!
implementation!of!related!guidelines,!policies!and!services.!
An! audit! of! this! scale! is! no! easy! task! but! it! is! however! necessary.! This! review! of! the!
Ministry!of!Health!Cochlear!Implant!Programme!has!enabled!a!thorough!analysis!of!the!
strengths!of!the!programme!as!well!as!areas,!which!need!further!attention.!
I! am! greatly! pleased! with! the! success! of! the! programme.! Despite! the! high! costs,! the!
benefits! of! hearing! to! the! individual,! family! and! society! is! priceless.! The! Medical!
Development! Division! will! continue! to! support! and! develop! the! programme.! Every!
hearing!impaired!individual!in!our!community!must!never!be!marginalized!and!be!given!
the!opportunity!to!integrate!into!mainstream!society.!
!
!
!
Dato’(Dr(Hj(Azman(bin(Hj(Abu(Bakar(
Director(Medical(Development(Division,(Ministry(of(Health(
National MOH CI Programme: 5-Year Report 2009-2013|ms iv!
!
!
!
!
Foreword!!
By!the!Programme’s!Advisor!
!
!
The! National! Cochlear! Implant! Committee! Ministry! of! Health! (MOH)! in! collaboration!
with!The!National!ORL!Registry!(Hearing!&!Otology!related!disease!/Cochlear!Implant)!
and!Clinical!Research!Centre!(CRC)!is!honored!to!present!the!first!Outcome!Report!of!
the! National! MOH! Cochlear! Implant! Programme.! The! Otolaryngologists,! Audiologists!
and! Speech! Therapist! with! tireless! support! from! Medical! Development! Division! and!
CRC! have! contributed! significantly! to! the! data! collection! and! data! analysis.! These!
results! are! particularly! crucial! to! assist! managements! planning,! improvement!
measures,! set! up! related! policies! and! help! estimate! financial! burden! for! hearing! loss!
cases!in!years!to!come.!
This! report! will! also! help! in! the! planning! of! preventive! and! early! rehabilitative!
measures!for!early!detection!of!hearing!loss!among!newborn!and!children.!
I!would!like!to!congratulate!Dr!Zulkiflee!Salahuddin!and!his!team;!the!editors,!members!
of!writing!committee!and!members!of!the!source!data!providers!for!their!contributions!
to!this!report.!It!is!indeed!a!bold!step!as!very!few!centers!worldwide!produce!Outcome!
Report! on! Cochlear! implantation! at! a! national! level.! ! We! hope! that! every! members! in!
the! ORL! fraternity! will! continue! to! strive! to! improve! the! ongoing! data! collection! in!
order!to!produce!high!standards!of!evidence!based!reports!and!scientific!papers!in!the!
future.!
A! special! thanks! and! gratitude! to! the! Director! and! staff! of! CRC! Hospital! Sultanah!
Bahiyah!for!their!financial!and!technical!support.!!
!
(
(
(
(Datin(Dr(Siti(Sabzah(binti(Mohd(Hashim(
Advisor,(National(MOH(Cochlear(Implant(Programme,(
National(Advisor,(Otolaryngology(Services,(MOH.(
National MOH CI Programme: 5-Year Report 2009-2013|ms
v!
!
!
!
!
!
!
Foreword!!
By!the!Chairman!Of!The!National!MOH!Cochlear!Implant!!
Report’s!Committee!
We! are! honored! and! privileged! to! present! this! 2008P2013! Ministry! of! Health! (MOH)!
Cochlear! Implant! Programme! Outcome! Report.! The! idea! was! mooted! by! our! mentor,!
Dato!Dr!Abd!Majid,!who!retired!in!early!2015,!two!years!before!he!ended!his!tenure!as!
The! National! Advisor! in! Otolaryngology! (ORL)! and! chairman! of! the! MOH! national!
cochlear!implant!committee.!!
Since! then,! members! of! the! writing! committee! and! source! data! providers! have! had!
numerous! meetings.! It! was! a! lengthy! and! tedious! process! of! data! collection,! data!
cleaning,! analysis,! literature! review! and! report! writing.! ! This! was! followed! by! the!
tireless! effort! of! the! editorial! members! to! produce! a! comprehensive! yet! concise!
document.! It! was! not! an! easy! task,! as! it! required! sheer! commitment! and! cohesive!
teamwork!by!all!members!of!the!team.!The!task!of!completing!this!project!was!greatly!
aided! by! the! constant! support! and! guidance! by! our! new! National! Advisor! in!
Otolaryngology!(ORL),!Datin!Dr!Siti!Sabzah!who!is!also!involved!directly!in!this!report.!
We! would! like! to! extend! our! gratitude! to! the! Director! and! officers/staff! of! Medical!
Development! Division! for! their! continuous! support! and! guidance! in! preparing! this!
outcome!report.!
Clinical!Research!Centre!(CRC)!Hospital!Sultanah!Bahiyah!has!been!instrumental!in!the!
data! collection! and! statistical! analysis.! We! would! like! to! convey! our! gratitude! to! the!
Director!and!staff!for!their!financial!and!technical!support!in!preparing!this!report.!!
We! hope! this! report! will! provide! an! insight! into! the! MOH! National! Cochlear! Implant!
service;! the! report! displays! its! achievement! and! recommendations! to! improve! the!
service! in! the! future.! This! will! assist! future! planning! and! the! management! of! hearing!
impaired!patients!in!our!beloved!country.!
!
+
Dr(Zulkiflee(bin(Salahuddin(
Chairman,(National(MOH(Cochlear(Implant(Report(Committee(
National MOH CI Programme: 5-Year Report 2009-2013|ms vi!
MEDICAL(WRITING(COMMITTEE(
NAME(
Datin(Dr(Siti(Sabzah(Mohd(Hashim(
Dr(Zulkiflee(Salahuddin(
Dr(Philip(Rajan(
Dr(Tengku(Mohamed(Izam(bin(Tengku(
Kamalden(
REPRESENTATION(
Department!of!Otolaryngology,!
Hospital!Sultanah!Bahiyah,!Alor!Setar,!
Kedah!
Department!of!Otolaryngology,!
Hospital!Raja!Perempuan!Zainab!II,!
Kota!Bharu!
Department!of!Otolaryngology,!
Hospiral!Raja!Permaisuri!Bainun,!
Ipoh!
Department!of!Otolaryngology,!
Hospital!Sultan!Ismail,!Johor!Bharu!
Dr(Iskandar(bin(Hailani(
Department!of!Otolaryngology,!
Hospital!Kuala!Lumpur,!Kuala!
Lumpur!
Dr(Sobani(Din(
Department!of!Otolaryngology,!
Hospital!Sungai!Buloh,!Selangor!
Dr(Valuyeetham(Kamaru(Ambu(
Department!of!Otolaryngology,!
Hospital!Tuanku!Jaafar,!Seremban!
En(Shahrul(Aiman(bin(Soelar(
Clinical!Research!Centre,!Hospital!
Sultanah!Bahiyah,!Alor!Setar,!Kedah!
Pn(Mas(Diana(binti(Samsudin(
Department!of!Otolaryngology,!
Hospital!Kuala!Lumpur,!Kuala!
Lumpur!
Pn(Nur(Azyani(binti(Amri(
Department!of!Otolaryngology,!
Hospital!Sungai!Buloh,!Selangor!
Pn(Farah(Dalila(binti(Mohamed(Tahir(
Pn(Azmawanie(binti(Ab(Aziz(
Pn(Noormala(Anuar(Ali(
Department!of!Otolaryngology,!
Hospital!Sultanah!Bahiyah,!Alor!Setar,!
Kedah!
Department!of!Otolaryngology,!
Hospital!Raja!Perempuan!Zainab!II,!
Kota!Bharu!
Department!of!Otolaryngology,!
Hospital!Sungai!Buloh,!Selangor!
National MOH CI Programme: 5-Year Report 2009-2013|ms vii!
Pn(Norhana(binti(Abu(Seman@Talib(
Department!of!Otolaryngology,!
Hospital!Sultanah!Bahiyah,!Alor!Setar,!
Kedah!
En(Shahrom(bin(Ab(Rahman(
Department!of!Otolaryngology,!
Hospital!Raja!Perempuan!Zainab!II,!
Kota!Bharu!
En(Amirudin(bin(Mohamed(
Department!of!Otolaryngology,!
Hospital!Sultan!Ismail,!Johor!Bharu!
SUPPORTED(BY:(
Medical!Development!Division!
!
•
Dato’(Dr(Azman(bin(Abu(Bakar(
•
Dr(Patimah(binti(Amin(
Clinical!Research!Centre!
•
Ibtisam(binti(Ismail(
•
Zainab(binti(Shafie(
!
!
!
National MOH CI Programme: 5-Year Report 2009-2013|ms viii!
PARTICIPATING"CLINICAL"SITES"(SOURCE"DATA"
PROVIDERS)(
!
1.
(
!
!!
2.
(
(
HOSPITAL(SULTANAH(BAHIYAH((
•
•
•
•
•
•
•
HOSPITAL(KUALA(LUMPUR((
•
•
•
•
•
•
Dr!Iskandar!bin!Hailani!(
Mas!Diana!binti!Samsudin!(
Ummu!Athiyyah!binti!Abdul!Razak!
Ainnoor!Shafinas!binti!Buyong!
Marina!binti!Abdul!Malek!
Mohd!Safwan!bin!Yusof!
(
HOSPITAL(RAJA(PEREMPUAN(ZAINAB(II((
•
•
•
•
•
•
•
Dr!Zulkiflee!bin!Salahuddin!!
Shahrom!bin!Ab!Rahman!(
Suhaiful!Syahril!bin!Suhaimi!
Farisatul!Ummi!binti!Aripin!
Azmawanie!binti!Ab!Aziz!(
Analiza!Anis!binti!Ab!Aziz!
Noorfadillah!binti!Ab!Halim!
3.
(
(
(
(
4.
(
(
5.
(
(
(
!
Dr!Siti!Sabzah!binti!Mohd!Hashim!!
Dr!Norzi!binti!Gazali!!
Farah!Dalila!binti!Mohamad!Tahir!!
Alia!Nadiha!binti!Alias!
Norasuzi!binti!Abdul!Halim!
Norhana!binti!Abu!Seman@Talib!
Nurbaiti!binti!Mohamad!Adli!
HOSPITAL(SULTAN(ISMAIL,(JOHOR(BAHRU((
•
•
•
Dr!Tengku!Mohamed!Izam!Tengku!Kamalden!!
Amirudin!bin!Mohamed!!
Chong!Lun!Cheh(
HOSPITAL(TUANKU(JAAFAR,(SEREMBAN,(NEGERI(SEMBILAN((
• Dr!Valuyeetham!Kamaru!Ambu!!
• Norhidayah!binti!Mohd!Hatta!!
• Hanita!binti!Hashim(
• Wahida!binti!Mohd!Abdul!Wahab!(
• Ernie!Heliza!binti!Yusof(
National MOH CI Programme: 5-Year Report 2009-2013|ms
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6.
HOSPITAL(RAJA(PERMAISURI(BAINUN,(IPOH,(PERAK((
(
(
(
(
(
7.
•
•
•
•
•
Dr!Philip!Rajan!!
Raja!Faizatul!Balqis!binti!Raja!Muzaffar!Syah(
Mazly!Helmy!bin!Sulaiman!(
Noryantimarlina!binti!Abdullah!(
Lau!Wai!Yen(
HOSPITAL(SUNGAI(BULOH((
(
(
8.
(
!
•
•
•
•
•
•
Dr!Sobani!bin!Din!(
Dr!Fadzilah!binti!Ismail!!
Nur!Azyani!binti!Amri!
Wan!Basirah!binti!Wan!Abdullah(
Noormala!binti!Anuar!Ali!!
Rozila!binti!Sumardi!!
HOSPITAL(SULTANAH(NUR(ZAHIRAH(
(
Siti!Hazwani!binti!Yusoh!
Nurul!Fatehah!binti!Ismail!
!
HOSPITAL(QUEEN(ELIZABETH(
•
•
9.
(
Dr!Ong!Cheng!Ai!
Siti!Ladyia!binti!Mohd!Salleh!
Shahriman!bin!Shalihin!
Esther!Tuin!
!
NON(SATELLITE(HOSPITALS:(
!
!
Hospital!Sultan!Abdul!Halim!
!
!
!
!
!
•
•
•
•
:!
!
Anida!Yusof!
Ruby!Izyan!Atika!binti!Abu!Bakar!
Hospital!Tuanku!Fauziah!
!
:!
Shafida!Saiman!
!
!
Hospital!Pulau!Pinang!
!
!
!
!
!
!
:!
!
Ng!Boon!Kheng!
Kok!Lee!Theng!
!
Hospital!Bukit!Mertajam!
!
:!
Noorhafillah!binti!Abdul!Rahman!!
!
!
Hospital!Sibu! !
!
!
!
!
!
:!
!
Jenny!Lau!Yue!Jun!
Ling!Tiew!Hong!
!
!
Hospital!Duchess!of!Kent!
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!
!
!
!
:!
!
Merlinda!W.!Bernard!
Yeap!Choo!Er!
!
!
National MOH CI Programme: 5-Year Report 2009-2013|ms
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ABBREVIATIONS(
!
ORL!
Otolaryngology!
!
NORL!
National!Otolaryngology!Registry!
!
MOH!
Ministry!of!Health!
!
UNHS! !
Universal!Neonatal!Hearing!Screening!
!
CAP!
!
Categories!of!Auditory!Performance!
!
Cochlear!Implant!
!
Speech!Intelligibility!Rating!
!
Three!Frequencies!Average!
!
CI!
!
SIR!
!
3FA!
!
HTL! !
Hearing!Threshold!Level!
!
dBHL! !
Decibel!Hearing!Level!
!
National MOH CI Programme: 5-Year Report 2009-2013|ms
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GLOSSARY(
!
PRELINGUAL(
A!prelingual(deaf!individual!is!someone!who!was!born!with!a!hearing!loss!or!someone!
whose!hearing!loss!occurred!before!they!began!to!speak.!
!
POSTLINGUAL(
Post<lingual(deafness!is!deafness,!which!develops!after!the!acquisition!of!speech!and!
language!
!
CROSS<OVER:((
CrossPover! is! a! change! from! one! system! of! hearing! rehabilitation! to! another! i.e.! from!
hearing!aid!to!cochlear!implant.!
!
SENSORINEURAL(HEARING(LOSS(
Sensorineural(hearing(loss!(SNHL)!is!a!type!of!hearing!loss,!or!deafness,!in!which!the!
root! cause! lies! in! the! inner! ear! (cochlea! and! associated! structures),! vestibulocochlear!
nerve!(cranial!nerve!VIII),!or!central!auditory!processing!centers!of!the!brain.!
!
COCHLEAR(IMPLANT(
A! cochlear( implant! (CI)! is! a! surgically! implanted! electronic! device! that! provides! a!
sense! of! sound! to! a! person! who! is! profoundly! deaf! or! severely! hard! of! hearing.! The!
receiver! picks! up! digital! signs! forwarded! by! the! transmitter,! and! converts! them! into!
electrical! impulses.! These! electrical! impulses! flow! through! electrodes! contained! in! a!
narrow,!flexible!tube!that!has!been!threaded!into!the!cochlea.!
!
(RE)HABILITATION(
Providing!different!types!of!therapies!to!patients!who!have!deafness,!and!implementing!
different!amplification!devices!to!aid!the!client’s!hearing!abilities.!Aural!rehab!includes!
specific! procedures! in! which! each! therapy! and! amplification! device! has! as! its! goal! the!
habilitation!or!rehabilitation!of!persons!to!overcome!the!handicap!(disability)!caused!by!
a!hearing!impairment!or!deafness.!
!
NEONATAL(HEARING(SCREENING(
An!objective!screening!method!performed!to!identify!neonates!who!may!have!hearing!
loss!and!who!need!follow!up!or!more!in!depth!testing.!
!
HEARING(THRESHOLD(
Minimum! sound! level! of! a! pure! tone! that! an! individual! can! hear! with! no! other! sound!
present!
!
BEHAVIOURAL(ISSUE((
Behavior! that! is! a! source! of! concern,! or! undesirable! that! may! impede! or! disrupt! the!
course!of!rehabilitation!process.!
National MOH CI Programme: 5-Year Report 2009-2013|ms xii!
HOME(BASE(PROGRAM(
Continuation! of! therapy! session! at! patient’s! home! as! the! follow! up! of! formal! therapy!
session! in! hospital.! This! is! to! be! conducted! by! parents! or! caregiver(s)! based! on! the!
guide!given!by!the!therapist.!
!
SWITCH(ON(
“Switch!on”!is!a!process!whereby!the!user’s!cochlear!implant!is!first!MAPped!(activated)!
postPoperatively.!This!usually!occurs!in!two!to!three!weeks!postPoperation.!!
!
MAPPING(
“MAPping”!is!a!process!of!getting!the!CI!user!a!specific!listening!program!(also!known!as!
MAP)! The! MAP! usually! consist! of! minimum! levels! of! audibility,! maximum! levels! of!
comfortability,!programming!strategy!and!other!associated!programming!options.!
!
!
!
National MOH CI Programme: 5-Year Report 2009-2013|ms xiii!
LIST%OF%TABLES%AND%FIGURES(
Table!1:!The!Categories!of!Auditory!Performance!Score!(Archbold!et!al.,!1995)!.!.............!10!
Table!2:!Speech!Intelligibility!Rating!Criteria!(Cox!&!McDaniel,!1989)!...................................!11!
Table!3:!Descriptive!Statistics!for!Prelingual!Group!........................................................................!17!
Table!4:!Surgical!complications!................................................................................................................!18!
Table!5:Mean!aided!thresholds!for!pre!and!post!implant.!............................................................!19!
Table!6:!Descriptive!statistics!for!CAP!score!at!24!months!for!prelingual!group!...............!20!
Table!7:Changes!at!6!months,!12!months!and!24!months!of!CAP!score!.................................!21!
Table!8:!Descriptive!statistics!for!SIR!scale!at!24!months!.............................................................!22!
Table!9:Changes!at!6!months,!12!months!and!24!months!of!SIR!score!...................................!23!
Table!10:!Trends!in!the!duration!of!1st!word!production!by!“age!at!surgery!group”!.......!24!
Table!11:!Association!between!variables!and!CAP!score!at!24!months!..................................!26!
Table!12:!Association!between!variables!and!SIR!scale!at!24!months!....................................!27!
Table!13:!Surgical!Complications!(Postlingual!&!CrossPOver!Group)!......................................!28!
Table!14:Mean!Aided!Threshold!Pre!and!PostPimplant!for!Postlingual!&!CrossPOver!!
!!!!!!!!!!!!!!!!!!Group!.................................................................................................................................................!29!
Table!15:!Descriptive!statistics!for!Postlingual!and!CrossPOver!Group!..................................!30!
Table!16:Changes!at!6!months,!12!months!and!24!months!of!CAP!score!for!Postlingual!&!!
!!!!!!!!!!!!!!!!!!CrossPOver!Group!........................................................................................................................!31!
(
Figure!1:!Stages!of!candidacy!selection!...................................................................................................!3!
Figure!2:Changes!at!6!months,!12!months!and!24!months!of!CAP!score!................................!21!
Figure!3:Changes!at!6!months,!12!months!and!24!months!of!SIR!scale!..................................!23!
Figure!4:Trends!in!the!duration!of!1st!word!production!by!age!at!surgery!group!............!24!
Figure!5:Changes!at!6!months,!12!months!and!24!months!of!CAP!scorefor!Postlingual!&!!
!!!!!!!!!!!!!!!!!CrossPOver!Group!.........................................................................................................................!31!
1
National MOH CI Programme: 5-Year Report 2009-2013|ms xiv!
CHAPTER 1
INTRODUCTION
INTRODUCTION(
The!first!commercial!multichannel!cochlear!implants!(CI)!were!produced!in!the!
1980’s.! The! device! was! initially! used! for! deaf! adults! and! eventually! was! successfully!
used! on! children.! One! of! the! truly! amazing! aspects! of! this! new! technology! was! the!
outcome! in! congenitally! deaf! children;! who! were! able! to! hear! and! speak! and! even! fit!
into! mainstream! education.! The! downside! to! this! success! was! the! huge! costs! in! the!
device,!time!required!for!habilitation!and!the!unpredictability!of!the!outcome.!However!
cumulative! experience! over! the! years! have! enabled! professionals! to! formulate!
guidelines!on!candidate!selection!and!expected!outcomes.!
Cochlear! implantation! has! been! accepted! as! one! of! the! treatment! of! choice! in!
patients!with!severe!to!profound!hearing!loss!that!failed!or!having!minimal!benefit!from!
hearing! aids.! Based! on! FDA! (Food! and! Drug! Administration)! information,!
approximately! 324,200! people! worldwide! have! received! cochlear! implants! as! of!
December!2012!(NIDCD!Information!Clearinghouse,!2011).+
The! Ministry! of! Health! Malaysia! officially! started! its! own! cochlear! implant!
programme! in! the! year! 2008.! A! central! committee! was! formed! by! the! Medical!
Development!Division,!MOH!and!comprised!of!professionals!from!MOH,!representative!
from!Ministry!of!Education!and!advisors!from!the!local!universities.!At!the!inception!of!
the! programme,! seven! centres! were! selected! to! begin! this! service.! This! included!
Hospital!Sungai!Buloh,!Hospital!Sultanah!Bahiyah,!Alor!Setar,!Hospital!Raja!Permaisuri!
Bainun,! Ipoh,! Hospital! Tuanku! Ja’afar,! Seremban,! Hospital! Sultan! Ismail,! Johor! Bahru,!
Hospital! Raja! Perempuan! Zainab! II,! Kota! Bharu! and! Hospital! Queen! Elizabeth,! Kota!
Kinabalu.! Hospital! Kuala! Lumpur! was! later! added! as! one! of! the! satellite! hospitals! in!
2009.! In! addition! to! the! above! hospitals,! Hospital! Sultanah! Nur! Zahirah,! Kuala!
Terengganu!was!also!designated!as!a!cochlear!implant!rehabilitation!center!for!the!east!
coast.!(
Adequate!staffing!and!equipment!needs!were!first!addressed!to!start!the!service.!
Staffing! requirements! included! trained! ORL! surgeons! in! Cochlear! Implant! surgery,!
audiologists! and! speech! therapists.! Necessary! surgical,! audiological! and! habilitation!
equipment! were! acquired! for! these! centres.! These! include! high! end! operating!
microscopes,! surgical! instrument! sets,! mastoid! drills,! facial! nerve! monitors,!
National MOH CI Programme: 5-Year Report 2009-2013|ms
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electrophysiological! diagnostic! set,! hearing! aid! analyzer! and! programmer,! speech!
language!assessment!and!stimulation!tools.!!
A! Cochlear! Implant! Service! Operational! Policy! (SOP)! was! also! developed! to!
ensure!a!high!professional!and!ethical!standard!of!practice!is!achieved!in!the!Ministry!of!
Health!hospitals!(Cochlear!Implant!Service!Operational!Policy,!MOH,!2009).!!
Candidate! selection! was! done! through! a! rigorous! multidisciplinary! assessment!
by! ORL! surgeons,! audiologists,! speech! therapists,! pediatricians,! radiologists,! medical!
social! welfare! officers,! psychologists,! occupational! therapists! and! other! relevant!
professionals.! Primary! candidacy! evaluation! was! done! at! the! satellite! hospitals! with!
final!approval!at!a!centralized!meeting!held!at!regular!intervals.!Candidacy!selection!is!
based!on!the!criteria!set!in!the!service!operating!policy.!Majority!of!the!candidates!were!
provided! with! a! cochlear! implant! from! an! annual! grant! allocated! by! the! Ministry! of!
Health,! Malaysia.! The! remaining! candidates! were! either! funded! by! other! government!
agencies,!external!sources!or!selfPfunded.!!
SATELLITE!HOSPITALS!
Candidacy!selection!
NATIONAL!MOH!CI!COMMITTEE!
Final!approval!
SURGERY(
!
Figure(1(:(Stages(of(candidacy(selection(
!
National MOH CI Programme: 5-Year Report 2009-2013|ms
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Surgeries!were!performed!using!a!standard!technique!of!cortical!mastoidectomy!
via!a!post!auricular!incision!followed!by!posterior!tympanotomy.!The!electrodes!were!
introduced!either!through!a!cochleostomy!or!round!window!approach.!The!procedures!
were!performed!by!trained!cochlear!implant!surgeons!from!the!satellite!hospitals!in!the!
presence!of!a!senior!surgeon!from!the!central!committee.!The!implants!used!were!from!
MedPEl!and!Cochlear.!
Audiologist! will! perform! impedance! and! intraoperative! neural! telemetry! while!
the! patient! is! under! general! anesthesia.! The! test! result! may! provide! useful! objective!
information!on!electrode!placement!and!baseline!information!for!switch!on!and!future!
mapping!session.!Switch!on!of!the!device!is!scheduled!two!weeks!post!operatively!and!
followed!by!regular!MAPping!sessions.!
The!patients!will!then!undergo!intensive!audiological!and!speech!(re)habilitation!
programme.! The! cochlear! implant! team! in! each! satellite! center! monitors! the! patient’s!
progress.!The!surgical!and!functional!outcomes!are!discussed!in!the!Central!Committee!
regularly.!!
National MOH CI Programme: 5-Year Report 2009-2013|ms
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!
CHAPTER 2
OBJECTIVE
!
!
!
!
!
!
!
!
!
!
(
(
(
(
(
(
(
(
(
(
(
OBJECTIVE(
!
The! aim! of! this! report! is! to! evaluate! the! success! of! the! program! and! to! identify! areas!
that!require!further!attention!or!improvement.!
!
a. To!describe!the!socio!demographic!variation!of!cochlear!implantees!in!the!
National!MOH!Cochlear!Implant!Programme.!
!
• To! determine! the! distributions! of! congenital,! syndromic! and! acquired!
hearing!loss!among!implantees.!!
!
b. To!determine!the!surgical!outcomes!in!the!first!5!years!since!the!initiation!of!the!
programme.!
!
•
To!determine!the!safety!of!the!surgical!procedure,!including!its!complication!
and!to!compare!results!with!other!Cochlear!Implant!Centres!worldwide.!
!
!
c. To!determine!the!functional!outcomes!in!the!first!5!years!since!the!initiation!of!
the!programme.!
!
• To!determine!the!audiological!outcomes.!
• To!determine!the!speech!outcomes.!
!
!
d. To!determine!factors!affecting!outcomes!of!the!programme.!!
!
!
e. To!formulate!recommendation!to!improve!and!strengthen!the!programme!!
!
•
!
•
To!stimulate!and!facilitate!research!on!cochlear!implantation!based!on!
the!report.!!
To!facilitate!future!financial!planning!and!projection!to!strengthen!the!
programme.!
National MOH CI Programme: 5-Year Report 2009-2013|ms
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CHAPTER 3
METHODOLOGY
a. Data!Collection!
All!cochlear!implants!recipients!under!the!MOH!Cochlear!Implant!Programme!from!
2009! to! 2013! were! included! in! this! review.! Data! was! obtained! from! the! National! ORL!
Registry! –! Hearing! and! Otology! Related! Disease/Cochlear! Implant! (NORL).! Additional!
information!was!acquired!from!the!CI!database!of!the!satellite!hospitals.!
b. Measuring!Level!Of!Outcomes!
The!outcomes!were!measured!by!surgical!complications,!aided!threshold,!auditory!
perception! and! speech! production.! ! Factors! contributing! to! the! outcomes! were! also!
analyzed.!!
1. Surgical(Complications(
A!surgical!complication!was!defined!as!an!unexpected!medical!event!related!to!the!
procedure! itself! and! causing! additional! morbidity! (e.g.! vertigo! or! infection)! or! a!
need!for!additional!surgery!(e.g.!electrode!migration).!
The! surgical! complications! were! characterized! as! major! or! minor.! Major!
complication!was!defined!as:!
I.
II.
a!significant!medical!problem!(e.g.!meningitis)!
an! event! leading! to! additional! major! surgery! due! to! a! patient! related!
problem! (e.g.! cholesteatoma! or! explantation! of! the! device! for! any! other!
reason!than!device!related!failure)!
III.
any!degree!of!permanent!disability!(e.g.!permanent!facial!nerve!paresis)!
Any! complication! not! falling! into! at! least! one! of! the! abovePmentioned! categories!
was! classified! as! minor! complications.! Minor! complications! include! wound!
infection,! delayed! wound! healing! which! do! not! need! surgical! intervention! and!
transient!facial!paresis!(Jeppesen!&!Emil!Faber,!2013).!!
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2. Aided(Thresholds(
The!aided!sound!field!thresholds!are!valuable!tools!in!assessing!the!performance!of!
hearing! aid! amplification,! cochlear! implant! and! middle! ear! implant.! It! is! widely!
used!in!pediatric!population!as!it!offers!behavioral!measures!(Hawkins,!2004)!
In! this! study! the! performance! of! three! frequencies! average! (500Hz,! 1000Hz! and!
2000Hz)!aided!thresholds!are!divided!into!two:!below!40dBHL!and!above!40dBHL.!
Studies! have! shown! that! with! aided! threshold! below! 40dBHL,! the! child! is! able! to!
hear!at!least!50%!of!what!is!being!said!(Madell,!2015).!!
3. Auditory(Perception(
Auditory!perception!was!measured!using!Categorical!Auditory!Performances!(CAP)!
scale!(Table!1).!The!CAP!is!a!global!outcome!measure!and!it!comprises!a!nonlinear!
hierarchical! scale! of! auditory! receptive! abilities;! the! lowest! level! describes! no!
awareness! of! environmental! sounds,! and! the! highest! level! is! represented! by! the!
ability!to!use!the!telephone!with!a!known!speaker!(Archbold,!Lutman,!&!Marshall,!
1995;!Raeve,!2010).!
4. Speech(Production(
Speech!production!was!measured!using!Speech!Intelligibility!Rating!Scale!(SIR)!and!
timing!of!first!word!production.!
The!SIR!was!used!to!measure!the!outcome!of!cochlear!implantation!with!respect!to!
speech!intelligibility!recognizable!by!the!listener.!It!is!a!5Ppoint!rating!scale!ranging!
from! ‘prePrecognizable! words! in! spoken! language’! to! ‘connected! speech! is!
intelligible!to!all!listeners’!(Cox!&!McDaniel,!1989;!Raeve,!2010)!(Table!2).!
National MOH CI Programme: 5-Year Report 2009-2013|ms
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Category1
01
11
21
31
41
51
61
71
Categorical1Auditory1Performances1(CAP)1Criteria1
No1awareness1of1environmental1sounds:1
Wearing!appropriate!aids!with!good!earmoulds,!the!child!does!not!alert!
spontaneously!to!any!environmental!sounds.!Nor!has!the!child!been!reported!to!
alert!to!environmental!sounds!
Awareness1of1environmental1sounds:1
The!child!has!been!observed!to!make!a!spontaneous!reaction!to!about!half!a!
dozen!different!environmental!sounds!(at!home,!at!school,!in!the!clinic!or!
outdoors).!The!reaction!need!not!indicate!that!the!child!recognizes!the!sound,!
only!that!he!or!she!has!detected!it.!
Response1to1speech1sounds:1
The!child!will!obey!a!simple!command,!such!as!the!instruction!‘Go’!to!perform!an!
action!such!as!rolling!a!ball!at!a!skittle,!when!delivered!in!a!normal!
conversational!sound!level!at!a!distance!of!1F2!feet.!
Identification1of1environmental1sounds:1
The!child!has!been!observed!to!identify!a!range!of!about!half!a!dozen!
environmental!sounds!consistently!in!everyday!life!!(e.g.!doorbell,!telephone,!
parent’s!voice,!traffic!etc).!Observers!are!confident!that!the!child!is!monitoring!
his!or!her!environment!via!audition.!
Discrimination1of1some1speech1sounds1without1lipFreading:1
The!child!can!discriminate!consistently!any!combination!of!two!of!!Ling’s!five!
sounds!(/ss/,!!/sh/,!/ee/,!/oo/,!/aa/)!presented!with!live!voice!at!a!conversational!
level!without!lipreading.!
Understanding1of1common1phrases1without1lipFreading:1
The!child!is!able!to!identify!common!phrases!in!a!familiar!constraining!context.!
For!example,!the!child!can!perform!the!IOWA!ClosedFSet!Sentence!Test!at!Level!
A;!or!the!child!can!identify!simple,!familiar!questions!in!a!known!context!(e.g.!
‘What’s!your!name?’,!‘Where’s!mummy?’,!‘How!old!are!you?’);!or!!the!child!can!
identify!a!picture!correctly!from!a!limited!set!when!the!picture!is!described!
verbally!
Understanding1of1conversation1without1lipFreading:1
The!child!can!carry!out!a!simple!unscripted!conversation!with!a!familiar!talker!
(e.g.!a!parent!or!teacher)!without!lipreading!in!a!quiet!setting.!The!child!must!be!
able!to!respond!correctly!to!simple!questions!without!interaction!breaking!down!
Use1of1telephone1with1known1listener:11
The!child!can!sustain!a!simple!unscripted!conversation!on!the!telephone!with!a!
familiar!talker.!The!child!must!be!able!to!respond!correctly!to!simple!questions!
without!interaction!breaking!down!
Table(1:(The(Categories(of(Auditory(Performance(Score((Archbold(et(al.,(1995)(.
National MOH CI Programme: 5-Year Report 2009-2013|ms 10!
Category(
Category!1!
Category!2!
Category!3!
Category!4!
Category!5!
Speech(Intelligibility(Rating((SIR)(Criteria(
Connected!speech!is!unintelligible.!Prerecognizable!words!in!spoken!
language,!primary!mode!of!communication!may!be!manual.!
Connected!speech!is!unintelligible.!Intelligible!speech!is!developing!
in!single!words!when!context!and!lipSreading!cues!are!available.!
Connected!speech!is!intelligible!to!a!listener!who!concentrates!and!
lipSreads.!
Connected! speech! is! intelligible! to! a! listener! who! has! little!
experience!of!a!deaf!person’s!speech.!
Connected!speech!is!intelligible!to!all!listeners.!Child!is!understood!
easily!in!everyday!contexts.!
Table(2:(Speech(Intelligibility(Rating(Criteria((Cox(&(McDaniel,(1989)(
!
5. Timing(of(First(Word(Production(
The!timing!of!first!word!production,!was!used!to!measure!the!outcome!of!CI!with!respect!
of! the! emergence! of! first! meaningful! word! produced! post! implantation.! There! is! a! large!
increase!in!canonical!and!post!canonical!utterances!after!5!months!of!implant!use!(Ertmer,!
2001)! .! Increases! in! diversity! of! consonant! types! and! features! suggested! that! auditory!
information! was! used! to! increase! phonetic! diversity.! It! has! been! shown! that! this!
advancement! to! higher! levels! of! vocal! development! have! been! interpreted! as! signs! of!
progress!toward!meaningful!speech!and!phonological!organization.!
c. Factors!Affecting!Outcomes!
In!this!study,!a!number!of!parameters!were!looked!into!their!possible!correlation!with!the!
outcomes.! They! are! parents’! education! levels,! the! total! household! income,! frequency! of!
(re)! habilitation! sessions,! post! implant’s! parental! commitment,! post! implant! home! base!
program,!three!frequencies!average!aided!hearing!threshold!level,!compliance!of!cochlear!
implant!usage!and!behavioral!issue.!
Parental!commitments!were!evaluated!under!criteria!that!include!compliance!to!the!given!
appointment,!attend!appointment!on!time!and!parents!involvement!in!sessions.!
Post!implant!home!based!programme!(HBP)!were!assessed!by!consistency!in!carrying!out!
HBP!and!initiative!to!create!their!own!therapy!materials.!
National MOH CI Programme: 5-Year Report 2009-2013|ms 11!
For! behavioral! issues,! patients’! behavior! was! gauged! under! five! (5)! criteria! which!
includes,!the!evaluation!of!patient’s!compliance!towards!behavioral!task,!participation!in!
the! sessions,! attention! span,! parental! reports! regarding! the! patient’s! behavior! at! home!
and!sitting!behavior.!!!
d. Statistical!Analysis!
1. Prelingual!
The! analyses! were! performed! with! IBM! SPSS! Statistics! for! Windows! software! (Version!
20.0.! Armonk,! NY:! IBM! Corp).! Descriptive! statistics! were! utilized! for! selected! variables.!
The! results! were! presented! as! frequencies! and! percentage! for! categorical! data! while! in!
numerical,!which!is!normally!distributed,!was!presented!as!mean!and!standard!deviation!
while! median! and! interquartile! range! was! presented! for! numerical! data,! which! is! not!
normally!distributed.!!
Pearson! ChiPsquare! test! was! used! to! compare! differences! in! categorical! data! among!
groups! (Surgery! success,! 3FA! aided! HTL,! CAP! score! at! 24! months! and! SIR! scale! at! 24!
months)!while!Fisher's!Exact!was!used!as!an!alternative!if!the!assumptions!of!Pearson!ChiP
square!not!met.!!
Comparing! numerical! (Mean)! data,! which! are! normally! distributed! between! two! groups,!
was! analyzed! using! the! Independent! tPtest! while! onePway! ANOVA! test! was! used! to!
compare!more!than!three!groups.!!
For! numerical! (Median)! data! which! is! not! normally! distributed! cause! of! outliers,!
comparing!numerical!data!between!the!two!groups!was!analyzed!using!the!MannPWhitney!
test!while!KruskalPWallis!test!was!used!to!compare!more!than!three!groups.!Spearman's!
rank!correlation!coefficient!was!used!to!study!the!heteroscedasticity!correlation!between!
age!at!diagnosis,!waiting!time,!age!at!surgery,!age!at!switch!on,!duration!of!switch!on!and!
duration!of!1st!word!production.!!
Repeated! measures! ANOVA! was! used! to! test! changes! at! 6! months,! 12! months! and! 24!
months!of!CAP!score!and!SIR!scale.!The!symmetrical!distribution!of!probabilities!dividing!
the!alpha!level,!usually!0.05!into!two!parts!(Lang!&!Secic,!2006)!and!the!probability!value!
of!less!than!0.05!(pPvalue!<!0.05)!was!considered!as!statistically!significant.(
National MOH CI Programme: 5-Year Report 2009-2013|ms 12!
2. Postlingual!&!Cross,Over!Group!
The! analyses! were! performed! with! IBM! SPSS! Statistics! for! Windows! software! (Version!
20.0.! Armonk,! NY:! IBM! Corp).! Descriptive! statistics! were! utilized! for! selected! variables.!
The! results! were! presented! as! frequencies! and! percentage! for! categorical! data! while! in!
numerical!was!presented!as!mean!and!standard!deviation.!!
Pearson! ChiPsquare! test! was! used! to! compare! differences! in! categorical! data! among!
groups! (CrossPover! and! postlingual! cochlear! implant! patients)! while! Fisher's! Exact! was!
used! as! an! alternative! if! the! assumptions! of! Pearson! ChiPsquare! not! met.! Comparing!
numerical!(Mean)!data!between!crossPover!and!postlingual!cochlear!implant!patients!was!
analyzed!using!the!Independent!tPtest.!!
Repeated! measures! ANCOVA! was! used! to! test! changes! at! 6! months,! 12! months! and! 24!
months!of!CAP!score!by!controlling!for!age.!The!symmetrical!distribution!of!probabilities!
dividing! the! alpha! level,! usually! 0.05! into! two! parts! (Lang! &! Secic,! 2006)! and! the!
probability! value! of! less! than! 0.05! (pPvalue! <! 0.05)! was! considered! as! statistically!
significant.!
e. Limitation!Of!The!Study!
As! it! is! a! retrospective! study,! inherent! biases! in! data! recording! and! collection! were!
unavoidable.!!
CAP! &! SIR! could! not! be! analyzed! in! some! of! the! patients! who! were! implanted! at! later!
period!of!the!study,!as!they!did!not!complete!the!24!months!observation!period!at!the!time!
of!data!collection.!!
Data!collection!in!number!of!patients!was!incomplete!as!they!were!lost!to!follow!up.!
!
National MOH CI Programme: 5-Year Report 2009-2013|ms 13!
(
CHAPTER 4
RESULTS
Demographic!Data!
In!the!period!between!2009!and!2013!a!total!of!184!CI!surgeries!were!performed!of!
which!there!were!128!prelingual!deaf!children!15!cross!over!and!41!Postlingual!deaf!
patients.!
a. Prelingual!Group!
There!were!128!prelingual!cochlear!implant!patients!in!the!period!between!2009!and!
2013.!Nine!of!them!were!excluded!from!the!study!as!they!were!not!compliant!to!the!
follow!up!schedule.!
Out!of!119!implantees,!53!were!male!and!66!were!female.!In!term!of!ethnicity,!Malay!
was!majority!(66.4%)!followed!by!Chinese!(21.8%),!Indian!(9.2%)!and!others!(2.5%).!
The!age!of!implantees!range!from!11.8!months!to!70.3!months!old.!
Indication!for!cochlear!implantation!was!bilateral!severe!to!profound!sensorineural!
hearing! loss.! Majority! of! them! were! congenital! nonPsyndromic! patients! (111!
patients).! Others! were! syndromic! patients;! 3! Waardenburg’s,! 1! Charge! Association!
and!1!Usher!Syndrome.!They!were!2!patients!with!Cochlear!malformations!(Mondini)!
and!1!with!acquired!cause.!!
Mean! age! at! diagnosis,! waiting! time,! age! at! surgery,! and! age! at! switch! on! for! our!
patients! was! 25.3,! 17.9,! 43.1! and! 44! months,! respectively.! ! Only! 10.1%! of! these!
patients!had!neonatal!hearing!screening.!
Majority! of! the! parents! (63.9! to! 72.3%)! acquired! nonPtertiary! education.! Most! of!
them!(84.9%)!had!household!incomes!of!less!than!RM!5000!monthly.!
National MOH CI Programme: 5-Year Report 2009-2013|ms 15!
Variable1
n"
Age1at1diagnosis,1months1
119!
Waiting1time,1months1
119!
Age1at1surgery,1months1
119!
!
!
!
!
Age1at1switch1on,1months1
7!
25S36!
14!
(11.8)!
37S48!
62!
(52.1)!
>49!
36!
(30.3)!
119!
119!
Duration1of11st1Word1Production,1months 1
96!
1
Gender1
!
!
!
!
Education1Level1(Father)1
!
!
Education1Level1(Mother)1
!
!
Household1Income1
!
!
!
!
Etiology1of1Hearing1Loss1
!
!
!
!
!
!
!
<24!
a
!
Race1
!
!
(5.9)!
Duration1of1switch1on,1months1
!
(%)1
!
!
!
Male!
1
53!
!
(44.5)!
Female!
66!
(55.5)!
Malay!
1
79!
!
(66.4)!
Chinese!
26!
(21.8)!
Indian!
11!
(9.2)!
Others!
3!
(2.5)!
Tertiary!
1
43!
!
(36.1)!
NonSTertiary!
76!
(63.9)!
Tertiary!
1
33!
!
(27.7)!
NonSTertiary!
86!
(72.3)!
<!RM1000!
1
15!
!
(12.6)!
RM1000!S!RM2499!
40!
(33.6)!
RM2500!S!RM4999!
46!
(38.7)!
RM5000!and!above!
18!
(15.1)!
1
111!
!
(93.3)!
3!
(2.5)!
2!
(1.7)!
1!
(0.8)!
1!
(0.8)!
1!
(0.8)!
Congenital!
Waardenburg!
syndrome!
Cochlear!
Malformation!
Acquired!
CHARGE!
Association!
Usher!syndrome!
Mean1
(SD)1
(1
Min1
,1
Max1 )1
25.3!
(9.65)!
(!
1.6!
,!
47.4! )!
17.9!
(8.86)!
(!
0.8!
,!
45.3! )!
43.1!
(9.69)!
(!
11.8!
,!
70.3! )!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
44.0!
!
(9.67)!
!
(!
!
12.7!
!
,!
!
!
71.2! )!
0.8!
(0.28)!
(!
0.3!
,!
1.6!
7.0!
(8.00)!
(!
0.0!
,!
36.0! )!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
National MOH CI Programme: 5-Year Report 2009-2013|ms 16!
)!
1
Neonatal1Hearing1Screening1
!
!
Surgical1complications1
!
!
!
3FA1Unaided1HTL1(dBHL)1
!
3FA1Aided1HTL1(dBHL)1
!
!
Yes!
1
12!
!
(10.1)!
!
!
!
!
!
!
!
No!
107!
(89.9)!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
Major!
1
2!
!
(1.7)!
!
!
!
!
!
!
!
Minor!
4!
(3.4)!
!
!
!
!
!
!
!
No!
113!
(95.0)!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
>80!dB!
1
!
119! (100.0)!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
<40!dB!
1
77!
!
(64.7)!
!
!
!
!
!
!
!
>41!dB!
42!
(35.3)!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
Note :aPresented as median (interquartile range);
SD = Standard Deviation.!
Table(3:(Descriptive(Statistics(for(Prelingual(Group
National MOH CI Programme: 5-Year Report 2009-2013|ms 17!
1. Surgical(Complications(
In!our!series,!there!was!no!mortality.!!
There! were! 2! major! complications;! the! first! patient! had! device! failure! 1! year! after!
implantation.! The! patient! was! reimplanted! in! the! same! ear.! The! second! patient!
developed! postauricular! abscess! one! year! following! implantation.! Management!
included!incision!and!drainage,!not!requiring!explantation.!
There!were!four!minor!complications.!One!patient!developed!transient!facial!paresis,!
which!recovered!with!conservative!measures.!Two!patients!had!wound!infection!and!
another! had! wound! breakdown! with! delayed! wound! healing.! They! were! managed!
conservatively.!There!was!no!complication!among!the!syndromic!children.!!
Summary!of!the!results!are!in!Table!4.!
MAJOR1COMPLICATION1
NO1OF1CASES1
Device!failure!
1!
Post!auricular!abscess!
1!
MINOR1COMPLICATION1
NO1OF1CASES1
Transient!facial!paresis!
1!
Wound!breakdown!
1!
Wound!infection!
2!
Table(4:(Surgical(complications
National MOH CI Programme: 5-Year Report 2009-2013|ms 18!
2. Aided(Threshold(
The!mean!aided!threshold!with!hearing!aids!measured!at!three!frequencies!average!
(500!Hz,!1000!and!2000!Hz)!prior!to!cochlear!implantation!was!80!dBHL.!Following!
implantation,!64.7%!patients!had!improvement!of!the!mean!aided!threshold!of!better!
than! 40! dBHL.! The! remaining! 35.3%! of! patients! showed! mean! aided! threshold! of!
between!40!to!80!dBHL.!
1
Mean1Aided1Threshold1
dBHL1(3FA)1
N1
Percent1%1
PRE1IMPLANT1
80!
119!
100!
<40!
77!
64.7!
>40!
42!
35.3!
POST1IMPLANT1
Table(5:Mean(aided(thresholds(for(pre(and(post(implant.(
3. Categorical(Auditory(Performances((CAP)(Score(
CAP(score!was!measured!prior!to!implantation!and!at!6,!12!and!24!months!interval!
post! implantation.! The! implantees! were! grouped! according! to! their! age! at! surgery!
(Group!1:!less!than!24!months,!Group!2:!25P36!months,!Group!3!37P48,!Group!4!!>49!
months).!Pre!implantation!mean!CAP!score!was!0!for!all!age!group.!!!
About!78%!of!our!implantees!able!to!discriminate!speech!sounds!without!lip!reading!
at! 24! months! (CAP! score! 4! and! above);! and! 51%! of! our! patients! are! able! to!
understand! common! phrases! without! lip! reading! (CAP! score! 5! and! above)!
irrespective!of!age!of!implant!(Table!6).!!
The! CAP! score! for! all! age! group! showed! significant! improvement! at! 6,! 12! and! 24!
months!followPup!after!implantation!(p<!0.001)!(Table!7!&!Figure!2).!!
The!CAP!score!continued!to!improve!with!time!in!all!age!group.!!Children!implanted!
before!24!months!of!age!showed!more!rapid!improvement!(steeper!curve)!compared!
to!the!other!groups.!!Group!1!and!2!showed!higher!score!in!mean!CAP!at!24!months!
follow! up! as! compared! to! Group! 3! and! 4.! However! they! were! not! significant!
statistically!!(p=0.236).!
National MOH CI Programme: 5-Year Report 2009-2013|ms 19!
!
!
!
!
!
!
1!
0!
37.48!!
>49!(31)!
(0.0)!
(2.0)!
(0.0)!
!
(0.0)!
(1.0)!
!
(%)(
0(
1!
1!
0!
!
0!
2!
!
n"
(3.2)!
(2.0)!
(0.0)!
!
(0.0)!
(2.0)!
!
(%)(
1(
2!
5!
2!
!
0!
9!
!
n"
(6.5)!
(9.8)!
(15.4)!
!
(0.0)!
(9.0)!
!
(%)(
2(
!
(%)(
(9.8)!
(0.0)!
!
(0.0)!
5! (16.1)!
5!
0!
!
0!
10! (10.0)!
!
n"
3(
6!
15!
4!
!
2!
27!
!
n"
(19.4)!
(29.4)!
(30.8)!
!
(40.0)!
(27.0)!
!
(%)(
4(
11!
19!
1!
!
1!
32!
!
n"
(35.5)!
(37.3)!
(7.7)!
!
(20.0)!
(32.0)!
!
(%)(
5(
5!
5!
3!
!
2!
!
1
5!
n"
(16.1)!
(9.8)!
(23.1)!
!
(40.0)!
(15.0)!
!
(%)(
6(
1!
0!
3!
!
0!
4!
!
n"
(3.2)!
(0.0)!
(23.1)!
!
(0.0)!
(4.0)!
!
(%)(
7(
National MOH CI Programme: 5-Year Report 2009-2013|ms 20
Table&6:&Descriptive&statistics&for&CAP&score&at&24&months&for&prelingual&group&
0!
(
0!
1!
!
n"
25.36!
<24!
Age(at(Surgery,(months(
Overall(
(
Variable(
CAP(Score(at(24(months(
!
CAP(Score(
Variable(
n"
p/valuea(
6(months(
12(months(
24(months(
Mean( (SD)(
Mean( (SD)(
Mean( (SD)(
(
!
!
100!
Overall(
Age(at(Surgery,(months(
(
5!
<24!
!
13!
25/36!
!
37/48! 51!
!
31!
>49!
!
!!
!! !! !! !! !! !!
!!
!
!
! !
2.6! (1.38)!
! !
3.6! (1.39)!
3.4!!
2.6!
2.5!
2.8!
4.2!
3.9!
3.3!
3.7!
!(1.95)! !
(1.56)!
(1.32)!
(1.31)!
!(1.92)! !
(1.55)!
(1.34)!
(1.30)!
! !
4.4! (1.40)!
<0.001!
0.236!
5.0! (1.00)!
!
!
4.9! (1.75)! !
4.1! (1.33)! !
4.4! (1.38)! !
!!
Table&7:&Changes&at&6&months,&12&months&and&24&months&of&CAP&score&
!
6
5
CAP Score
4
3
2
1
0
Pre op
6 months
Overall
<24
12 months
25-36
37-48
24 months
>49
&
Figure&2:Changes&at&6&months,&12&months&and&24&months&of&CAP&score&
!
National MOH CI Programme: 5-Year Report 2009-2013|ms 21!
!
4. Speech&Intelligibility&Rating&Scale&(SIR)&
Speech&Intelligibility&Rating&Scale&(SIR)&was$measured$prior$to$implantation$and$at$
6,$ 12$ and$ 24$ months$ interval$ post$ implantation.$ The$ implantees$ were$ grouped$
according$ to$ their$ age$ at$ surgery$ (Group$ 1:$ less$ than$ 24$ months,$ Group$ 2:$ 25@36$
months,$ Group$ 3:$ 37@48,$ Group$ 4:$ >49$ months).$ The$ mean$ SIR$ score$ at$ pre$
implantation$was$1$for$all$groups.$
At$ 24$ months$ post$ implant,$ about$ 71.1%$ of$ our$ implantees$ are$ able$ to$ produce$
intelligible$ speech$ in$ single$ words$ when$ context$ and$ lip$ reading$ cues$ are$ available$
(SIR$ score$ 2$ and$ above);$ and$ 38.1%$ of$ our$ patients$ are$ able$ to$ produce$ intelligible$
speech$ to$ a$ listener$ who$ concentrates$ and$ lip$ reads$ (SIR$ score$ 3$ and$ above)$
irrespective$of$age$of$implant$(Table$8).$$
The$SIR$score$for$all$groups$showed$significant$improvement$at$6,$12$and$24$months$
follow@up$after$implantation$(p<$0.001)$(Table$9).$$
The$SIR$score$continued$to$improve$with$time.$Children$implanted$before$24$months$
of$ age$ showed$ more$ rapid$ improvement$ (steeper$ curve)$ compared$ to$ the$ other$
groups.$$Group$1$and$2$showed$higher$mean$score$at$24$months$follow$up,$whereas$
Group$3$and$4$were$noted$to$have$poorer$performance$than$the$overall$score$(figure$
3).#
Variable(
(
#
Overall(
Age(at(Surgery,(months(
<24#
#
25/36#
#
37/48#
#
>49#
#
#
#
SIR(Scale(at(24(months(
2(
3(
4(
n" (%)(
n" (%)(
n" (%)(
1(
n" (%)(
5(
n" (%)(
# #
# #
# #
# #
28# (28.9)# 32# (33.0)# 30# (30.9)# 4# (4.1)#
# #
3# (3.1)#
(
2#
2#
15#
9#
#
# #
# #
(40.0)# 1# (20.0)# 0# (0.0)#
(16.7)# 2# (16.7)# 7# (58.3)#
(30.0)# 19# (38.0)# 14# (28.0)#
(30.0)# 10# (33.3)# 9# (30.0)#
#
1#
1#
1#
0#
#
#
#
#
# #
#
1#
0#
1#
2#
#
(20.0)#
(0.0)#
(2.0)#
(6.7)#
# #
#
(20.0)#
(8.3)#
(2.0)#
(0.0)#
# #
Table&8:&Descriptive&statistics&for&SIR&scale&at&24&months&
National MOH CI Programme: 5-Year Report 2009-2013|ms 22#
#
SIR(Scale(
Variable(
n"
(
#
Overall(
Age(at(Surgery,(months(
<24#
#
25/36#
#
37/48#
#
>49#
#
a
6(months(
Mean( (SD)(
12(months(
Mean( (SD)(
24(months(
Mean( (SD)(
#
97#
# #
1.5# (0.74)#
# #
1.8# (0.86)#
# #
2.2# (1.01)#
(
5#
12#
50#
30#
#
2.2#
1.6#
1.4#
1.5#
#
2.4#
2.2#
1.6#
1.7#
#
2.6#
2.7#
2.1#
2.1#
#
(1.79)#
(0.67)#
(0.64)#
(0.63)#
#
(1.67)#
(0.94)#
(0.80)#
(0.70)#
Note: Repeated measures ANOVA (Time Effect) using Greenhouse-Geisser;
SD = Standard Deviation.#
#
#
(1.82)#
(1.07)#
(0.92)#
(0.94)#
p/valuea(
#
<0.001#
0.187#
#
#
Table&9:Changes&at&6&months,&12&months&and&24&months&of&SIR&score&
#
3
SIR Scale
2
1
0
Pre op
6 months
Overall
<24
12 months
25-36
37-48
#
#
#
#
24 months
>49
Figure&3:Changes&at&6&months,&12&months&and&24&months&of&SIR&scale&
National MOH CI Programme: 5-Year Report 2009-2013|ms 23#
5. First&Word&Production&
The$implantees$were$grouped$according$to$their$age$at$surgery$(Group$1:$less$than$
24$months,$Group$2:$25@36$months,$Group$3:$37@48$months$and$Group$4:$more$than$
49$months).$The$mean$duration$for$the$first$meaningful$word$production$for$all$age$
group$ was$ 7$ months$ after$ switch$ on.$ There$ is$ no$ significant$ statistical$ difference$
between$all$age$groups$(p=0.468).$$
Age(at(surgery,(months(
(
Variable(
(
"
(
Duration#of#1st#
Word#Production#
b
#
#
<24(
25/36(
n" Mean( (SD)(
n" Mean( (SD)(
#
6#
#
7.5#
#
#
(7.25)# 12#
37/48(
>49(
p/value(
n" Mean( (SD)( n" Mean( (SD)(
#
#
#
#
#
#
#
#
#
7.0# (10.50)# 47# 10.0# (9.00)# 31# 7.0# (9.00)# 0.468b#
Kruskal/Wallis#test,#presented#as#median(interquartile#range);#
#
SD#=#Standard#Deviation.#
Table&10:&Trends&in&the&duration&of&1st&word&production&by&“age&at&surgery&group”&
(
15
Months
10
5
0
<24
25-36
37-48
Age at surgery group
>49
Duration of 1st Word Production
Figure&4:Trends&in&the&duration&of&1st&word&production&by&age&at&surgery&group&
National MOH CI Programme: 5-Year Report 2009-2013|ms 24#
6. Factors&Affecting&Outcomes:&
There$are$a$number$of$factors$associated$with$good$CAP$score$(score$more$than$5).$
They$are$children$with$no$behavioural$issue$(p<0.001),$mean$aided$threshold$better$
than$40$dBHL$(p=$0.037)$and$good$compliance$of$using$CI$of$8$hours$and$more$daily$
(p=$0.015).$
Other$ factors$ such$ as$ parents’$ education$ level,$ family$ household$ income,$ and$
frequency$of$rehabilitation$session,$post$CI$parental$commitment,$and$post$CI$home$
based$programme$do$not$show$significant$correlation$with$good$CAP$score.$$
SIR$ score$ is$ significantly$ associated$ with$ post$ CI$ parental$ commitment$ (p=0.023),$
Post$CI$Home$based$programme$(p=0.019),$no$behavioural$issue$(p=0.002)$and$good$
compliance$of$using$CI$of$8$hours$and$more$daily$(p=$0.001).$
Other$factors$such$as$parents’$education$level,$family$household$income,$frequency$of$
rehabilitation$sessions$and$mean$aided$threshold$better$than$40$dBHL$do$not$show$
significant$correlation$with$good$SIR$score.$$
National MOH CI Programme: 5-Year Report 2009-2013|ms 25#
CAP(Score(at(24(months(
Variables(
#
#
Household(Income(
<#RM999#
#
RM1000#/#RM2499#
#
RM2500#/#RM4999#
#
RM5000#and#above#
#
Education(Level((Father)(
Tertiary#
#
Non/Tertiary#
#
Education(Level((Mother)(
Tertiary#
#
Non/Tertiary#
#
Frequency(of((Re)Habilitation(Sessions(
According#to#SOP#
#
Not#according#to#SOP#
#
Post(CI(Parental(Commitment(
Poor#
#
Good#
#
Post(CI(Home(Base(Program(
Poor#
#
Good#
#
Behavioural(Issue(
Poor#
#
Good#
#
3FA(Aided(HTL(
<40#dB#
#
>41#dB#
#
Compliance(of(CI(Usage(
<7#hours#per#day#
#
>8#hours#per#day#
#
0/4(
5/7(
n" (%)(
n" (%)(
#
(
7#
13#
19#
10#
#
#
(70.0)#
(36.1)#
(51.4)#
(58.8)#
#
#
3#
23#
18#
7#
#
#
(30.0)#
(63.9)#
(48.6)#
(41.2)#
( #
18# (51.4)#
31# (47.7)#
# #
17# (48.6)#
34# (52.3)#
( #
14# (50.0)#
35# (48.6)#
# #
14# (50.0)#
37# (51.4)#
( #
15# (45.5)#
34# (50.7)#
# #
18# (54.5)#
33# (49.3)#
( #
18# (64.3)#
31# (43.1)#
# #
10# (35.7)#
41# (56.9)#
( #
25# (58.1)#
24# (42.1)#
# #
18# (41.9)#
33# (57.9)#
( #
26# (86.7)#
23# (32.9)#
# #
4# (13.3)#
47# (67.1)#
( #
29# (42.0)#
20# (64.5)#
# #
40# (58.0)#
11# (35.5)#
( #
8# (88.9)#
41# (45.1)#
# #
1# (11.1)#
50# (54.9)#
p/value"
#
0.180b#
0.721
0.901
0.619
0.057
0.112
<0.001
0.037
#
#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
0.015
#
#
c#
#
#
Note:aIndependentt-test, presented as mean (standard deviation);
b
Pearson Chi-square test;
c
Fisher’s Exact test.
Table&11:&Association&between&variables&and&CAP&score&at&24&months&
&
National MOH CI Programme: 5-Year Report 2009-2013|ms 26#
SIR(Scale(at(24(months(
Variables(
1(
2/5(
n" (%)(
n" (%)(
#
#
# #
Household(Income(
( #
<#RM999#
3# (37.5)#
#
RM1000#/#RM2499#
6# (16.7)#
#
RM2500#/#RM4999#
10# (27.8)#
#
RM5000#and#above#
9# (52.9)#
#
Education(Level((Father)(
( #
Tertiary#
13# (37.1)#
#
Non/Tertiary#
15# (24.2)#
#
Education(Level((Mother)(
( #
Tertiary#
9# (32.1)#
#
Non/Tertiary#
19# (27.5)#
#
Frequency(of((Re)Habilitation(Sessions(
( #
According#to#SOP#
9# (28.1)#
#
Not#according#to#SOP#
19# (29.2)#
#
Post(CI(Parental(Commitment(
( #
Poor#
12# (46.2)#
#
Good#
16# (22.5)#
#
Post(CI(Home(Base(Program(
( #
Poor#
17# (41.5)#
#
Good#
11# (19.6)#
#
Behavioural(Issue(
( #
Poor#
15# (50.0)#
#
Good#
13# (19.4)#
#
3FA(Aided(HTL(
( #
<40#dB#
17# (25.0)#
#
>41#dB#
11# (37.9)#
#
Compliance(of(CI(Usage(
( #
<7#hours#per#day#
7# (77.8)#
#
>8#hours#per#day#
21# (23.9)#
#
!
Note:aIndependent#t/test,#presented#as#mean#(standard#deviation);#
b
Pearson#Chi/square#test.#
#
#
5#
30#
26#
8#
#
#
(62.5)#
(83.3)#
(72.2)#
(47.1)#
# #
22# (62.9)#
47# (75.8)#
# #
19# (67.9)#
50# (72.5)#
# #
23# (71.9)#
46# (70.8)#
# #
14# (53.8)#
55# (77.5)#
# #
24# (58.5)#
45# (80.4)#
# #
15# (50.0)#
54# (80.6)#
# #
51# (75.0)#
18# (62.1)#
# #
2# (22.2)#
67# (76.1)#
p/value"
#
0.052b#
0.176
0.650
0.910
0.023
0.019
0.002
0.198
0.001
#
#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
#
#
b#
#
#
Table&12:&Association&between&variables&and&SIR&scale&at&24&months&
National MOH CI Programme: 5-Year Report 2009-2013|ms 27#
b. Post'Lingual'And'Cross3Over'Group'
There$were$41$postlingual$cochlear$implant$and$15$cross@over$patients$in$the$period$
between$2009$and$2013.$
Among$56$implantees,$29$were$male$and$27$were$female.$In$term$of$ethnicity,$Malay$
was$majority$(78.6%)$followed$by$Chinese$(10.7%),$Indian$(8.9%)$and$others$(1.8%).$
The$age$of$implantees$range$from$3.6$years$to$63.2$years$old.$
Indication$for$cochlear$implantation$was$bilateral$severe$to$profound$sensorineural$
hearing$ loss.$ Majority$ of$ them$ were$ idiopathic$ (36$ patients).$ Others$ are$ familial$ (2$
patients),$ meningitis$ (5$ patients),$ trauma$ (9$ patients)$ and$ ear$ related$ disease$ (4$
patients).$
1. Surgical&complications&
In$ our$ series,$ there$ was$ no$ mortality.$ $ There$ were$ 2$ major$ complications,$ one$ is$ a$
case$ of$ electrode$ migration$ at$ 3$ months$ post$ first$ implantation,$ and$ 6$ months$ post$
second$ implantation.$ Another$ case$ involves$ device$ failures$ at$ about$ one$ year$ post$
implantation.$Both$patients$were$reimplanted$in$the$same$ear.$There$was$no$minor$
complication.$$
MAJOR(COMPLICATION(
NO(OF(CASES(
Device#failure#
1#
Electrode#Migration#
1#
Table&13:&Surgical&Complications&(Postlingual&&&CrossTOver&Group)
National MOH CI Programme: 5-Year Report 2009-2013|ms 28#
2. Aided&threshold&
The$ mean$ aided$ hearing$ threshold$ with$ hearing$ aids$ measured$ in$ the$ three$
frequencies$average$(500$Hz,$1000$and$2000$Hz)$prior$to$cochlea$implantation$was$
80$ dBHL.$ Following$ implantation,$ 82.1%$ patients$ had$ improvement$ of$ the$ mean$
aided$ threshold$ of$ better$ than$ 40$ dBHL.$ The$ remaining$ 17.9%$ of$ patients$ showed$
mean$aided$threshold$of$40$to$80$dBHL.$
(
PRE(IMPLANT(
POST(IMPLANT(
Mean(Aided(
Threshold((dBHL)(
N(
Percent(%(
80#
56#
100#
<40#
46#
82.1#
>40#
10#
17.9#
Table&14:Mean&Aided&Threshold&Pre&and&PostTimplant&for&Postlingual&&&CrossTover&
Group
3. Categorical&Auditory&Performances&(CAP)&test&
CAP$ score$ was$ measured$ prior$ to$ implantation$ at$ 6,$ 12$ and$ 24$ months$ post$
implantation.$The$implantees$were$grouped$according$to$cross$over$and$post$lingual$
group.$Pre$implantation$mean$CAP$score$was$0$for$all$age$group.$$$
At$ 24$ months$ post$ implant,$ 96.4%$ of$ our$ implantees$ were$ able$ to$ understand$
common$phrases$without$lip$reading$(CAP$score$5$and$above)$irrespective$of$age$of$
implant.$ Twenty@two$ implantees$ (39.3%)$ were$ able$ to$ use$ the$ telephone$ with$ a$
known$listener$(Table$14).$$
The$ CAP$ score$ for$ both$ groups$ (overall)$ showed$ significant$ improvement$ and$
achieved$CAP$score$of$6$at$24$months$after$implantation$(p<0.001)$(Table$15).$
The$CAP$score$showed$marked$improvement$at$the$first$6$months$post$implantation$
and$ continued$ to$ improve$ with$ time$ in$ both$ group.$ $ Post$ lingual$ group$ showed$
improvement$in$CAP$score$better$than$the$cross$over$group$within$6$and$12$months$
of$implantation$but$not$statistically$significant$(p=0.069)$after$age$adjustment.$$
#
National MOH CI Programme: 5-Year Report 2009-2013|ms 29#
#
Variable(
n" (%)(
Group(
Cross/over#
#
Postlingual#
#
Age,(yearsa(
Gender(
Male#
#
Female#
#
Race(
Malay#
#
Chinese#
#
Indian#
#
Others#
#
CAP(Score(at(6(months(
#
(
15#
41#
22.5#
#
(26.8)#
(73.2)#
(15.77)#
( #
29# (51.8)#
27# (48.2)#
(
44#
6#
5#
1#
#
(78.6)#
(10.7)#
(8.9)#
(1.8)#
( #
1# (1.8)#
1#
2#
#
3#
#
4#
#
5#
#
6#
#
7#
#
CAP(Score(at(12(months(
0#
#
4#
#
5#
#
6#
#
7#
#
CAP(Score(at(24(months(
0#
#
4#
#
5#
#
6#
#
7#
#
3FA(Aided(HTL(
<40#dB#
#
>40#dB#
#
Etiology(
Unknown#
#
Familial#
#
Meningitis#
#
Trauma#
#
Syndromic/Disease#
#
a
Note#: Presented#as#mean#(standard#deviation).#
#
2#
1#
10#
20#
16#
6#
(3.6)#
(1.8)#
(17.9)#
(35.7)#
(28.6)#
(10.7)#
(
1#
4#
15#
21#
15#
#
(1.8)#
(7.1)#
(26.8)#
(37.5)#
(26.8)#
(
1#
1#
10#
22#
22#
#
(1.8)#
(1.8)#
(17.9)#
(39.3)#
(39.3)#
( #
46# (82.1)#
10# (17.9)#
#
(
36#
2#
5#
9#
4#
#
#
(64.3)#
(3.6)#
(8.9)#
(16.1)#
(7.1)#
#
Table&15:&Descriptive&statistics&for&Postlingual&and&CrossTOver&Group
National MOH CI Programme: 5-Year Report 2009-2013|ms 30#
Variable(
( #
Overall(
Group(
Cross/over#
#
Postlingual#
#
# #
n"
CAP(Score(
12(months(
Mean( (SE)(
6(months(
Mean( (SE)(
24(months(
Mean( (SE)(
#
56#
# #
5.0# (0.20)#
# #
5.7# (0.19)#
# #
6.1# (0.18)#
(
15#
41#
# #
4.8# (0.38)#
5.2# (0.21)#
# #
5.6# (0.37)#
5.8# (0.20)#
# #
6.2# (0.35)#
6.0# (0.19)#
# #
#
#
#
#
p$valuea(
#
<0.001#
0.069#
#
#
#
#
Table&16:Changes at 6 months, 12 months and 24 months of CAP score for&
Postlingual&&&CrossTover&Group&
#
6$
5$
CAP&Score&
4$
3$
2$
1$
0$
Pre@Op$
6$months$
Overall$
12$months$
Cross@Over$
24$months$
Postlingual$
#
Figure&5:Changes at 6 months, 12 months and 24 months of CAP score for&Postlingual&
&&CrossTover&Group
National MOH CI Programme: 5-Year Report 2009-2013|ms 31#
&
&
&
(
CHAPTER 5
DISCUSSION
Age'Of'Diagnosis'And'Implantation'In'Prelingual'Patients'
From$our$study,$the$mean$age$at$diagnosis$is$25.3$months;$meanwhile$the$mean$age$
of$ surgery$ is$ 43.1$ months.$ Only$ 10%$ of$ these$ patients$ have$ undergone$ neonatal$
hearing$screening,$which$suggest$that$the$majority$of$the$patients$were$detected$via$
symptoms$of$delayed$speech$and$language$development.$In$MOH$hospitals$neonatal$
hearing$ screening$ is$ at$ infancy$ stage$ and$ only$ implemented$ in$ few$ state$ hospitals.$
Majority$ of$ the$ prelingual$ implantees$ were$ not$ detected$ through$ neonatal$ hearing$
screening$ programme,$ therefore$ it$ is$ recommended$ we$ should$ consolidate$ our$
national$neonatal$hearing$screening$programme.$
Joint$Committee$of$Infant$Hearing$(JCIH)$recommends$for$universal$neonatal$hearing$
screening$ by$ 1$ month$ of$ age,$ hearing$ identification$ at$ 3$ months$ and$ hearing$
intervention$at$6$months$of$age.$Delay$in$diagnosis$and$intervention$(cochlea$implant$
surgery),$will$affect$the$speech$and$language$outcome$in$our$implantees.$$
Surgical'Outcomes'
Cochlear$ implantation$ Programme$ in$ the$ MOH$ has$ shown$ to$ be$ safe$ with$ low$
complication$rate.$
The$ overall$ complication$ rate$ in$ our$ series$ was$ 4.3%.$ There$ were$ 4$ cases$ of$ major$
complication.$ There$ were$ two$ device$ failures,$ one$ electrode$ migration$ and$ one$
delayed$post$auricular$abscess.$$
The$ prelingual$ patient$ with$ device$ failure$ was$ detected$ at$ about$ 11$ months$ post$
implantation.$ This$ device$ was$ successfully$ explanted$ and$ reimplanted$ with$ a$ new$
device$ in$ the$ same$ ear.$ The$ device$ failure$ was$ due$ to$ dysfunctional$ electrodes.$ The$
second$ device$ failure$ occurred$ in$ a$ postlingual$ patient$ after$ about$ one$ year$ post$
implantation.$
The$particular$case$involving$electrode$migration$cannot$be$explained$satisfactorily$
because$it$occurred$twice$in$the$same$patient,$using$the$same$electrode.$This$could$be$
due$ to$ electrode$ rejection.$ The$ patient$ was$ successfully$ reimplanted$ using$ another$
specially$designed$electrode$(FORM%electrode$by$Med@El).$One$case$of$post$auricular$
National MOH CI Programme: 5-Year Report 2009-2013|ms 33#
abscess$occurred$one$year$following$the$implantation$and$had$to$undergo$surgery$to$
drain$the$abscess,$however,$the$implant$remain$functional.$$
There$were$four$minor$complications.$One$patient$developed$transient$facial$paresis,$
which$recovered$with$conservative$measures.$Two$patients$had$wound$infection$and$
another$ had$ wound$ breakdown$ with$ delayed$ wound$ healing.$ They$ were$ managed$
conservatively.$
The$ overall$ surgical$ complication$ in$ our$ program$ is$ low$ and$ it$ is$ comparable$ with$
other$large$series$with$complication$rates$of$5$–$20%(Jeppesen$&$Emil$Faber,$2013).%
$We$ believe$ that$ our$ surgical$ technique$ of$ avoiding$ big$ surgical$ flap,$ practice$ of$
supervised$ cochlear$ implant$ surgeries$ by$ senior$ otology$ surgeons$ and$ the$ usage$ of$
facial$nerve$monitor$in$all$cases$have$contributed$in$minimizing$the$complications.$$$
Functional'Outcomes'
The$CAP$score$has$many$advantages,$and$the$inter@observer$reliability$of$the$CAP$has$
been$ widely$ accepted.$ Differences$ in$ language$ competency$ are$ not$ critical$ for$
performing$the$tasks$of$this$test$and$it$can$be$used$in$children$at$any$age(Suh$et$al.,$
2009).$ Other$ studies$ assessing$ auditory$ performance$ outcome$ in$ cochlea$
implantation$also$use$CAP$scores$for$adult$population(Kameswaran,$Raghunandhan,$
Natarajan,$&$Basheeth,$2006).$
SIR$ was$ used$ to$ measure$ the$ speech$ intelligibility$ of$ the$ implanted$ children$ by$
quantifying$their$everyday$spontaneous$speech.$It$is$a$time$effective$global$outcome$
measure$ of$ speech$ intelligibility$ in$ real$ life$ situations$ (Allen,$ Nikolopoulos,$ &$
O’Donoghue,$1998).$
After$implantation,$the$CAP$and$SIR$scores$of$implantees$(prelingual,$cross$over$and$
post$ lingual)$ increased$ with$ increasing$ time$ of$ implant$ use$ during$ the$ implant$
period.$These$findings$show$that$there$is$improvement$of$auditory$performance$and$
speech$intelligibility$in$the$majority$of$our$patients$post$implantation.$
$
National MOH CI Programme: 5-Year Report 2009-2013|ms 34#
In$ the$ prelingual$ group,$ patients$ implanted$ early$ (less$ than$ 24$ months)$ performed$
better$in$their$CAP$and$SIR$scores$at$all$time$intervals$compared$to$those$implanted$
later$(more$than$24$months).$These$results$are$consistent$with$other$studies$that$find$
early$ implantation$ leads$ to$ better$ speech$ and$ language$ outcome$ (De$ Raeve$ &$
Wouters,$2013;$Zhou,$Chen,$Shi,$Wu,$&$Yin,$2013).$
$Early$implantation$allows$the$child$to$get$access$to$sound$and$spoken$language$from$
a$younger$age,$which$will$facilitate$better$speech$and$language$development.$$
Two$ important$ factors$ resulting$ in$ good$ CAP$ and$ SIR$ outcomes$ are$ implantees$
without$ behavioural$ issues$ (p<0.001,$ p=0.002)$ and$ good$ compliance$ of$ using$ CI$
(more$than$8$hours$daily)(p=0.015,p=0.001).$These$findings$suggest$that$behavioural$
assessment$ should$ be$ an$ important$ tool$ for$ candidacy$ selection.$ This$ study$ also$
shows$ that$ good$ compliance$ of$ CI$ usage$ is$ another$ important$ factor$ to$ have$ good$
outcome.$ In$ our$ programme,$ good$ compliance$ with$ HA$ usage$ is$ a$ prerequisite$ in$
candidacy$ selection,$ as$ we$ believe$ that$ this$ will$ reflect$ to$ the$ future$ CI$ usage$
compliance.$
Another$ variable$ that$ is$ associated$ with$ high$ CAP$ score$ is$ mean$ aided$ thresholds$
better$ than$ 40dBHL.$ This$ is$ consistent$ with$ Madell,$ 2012$ findings$ where$ children$
with$ hearing$ threshold$ of$ 40dBHL$ or$ better$ is$ able$ to$ hear$ at$ least$ 50%$ of$ what$ is$
being$said.$Therefore$this$correlates$with$better$CAP$scores.$
Our$ report$ also$ demonstrated$ that$ post$ CI$ parental$ commitment$ and$ good$
compliance$ to$ home$ based$ programme$ contribute$ to$ high$ SIR$ score$ (p=0.023,$
p=0.019).$ Therefore,$ it$ is$ important$ for$ family$ members$ to$ be$ involved$ and$ fully$
committed$in$providing$adequate$auditory$and$speech$input$at$their$home$settings$as$
per$ guided$ by$ the$ Speech$ Therapist$ and$ Audiologist.$ This$ aspect$ is$ especially$
important$ in$ our$ Malaysian$ setting$ due$ to$ the$ insufficient$ numbers$ of$ Audiologists$
and$especially$Speech$Therapists$in$the$MOH$hospitals$and$limited$early$intervention$
program$for$the$hearing$impaired$nationwide.$$
Besides$all$of$the$above,$in$our$series,$we$find$that$the$first$meaningful$word$emerge$
by$seven$months$post$switch$on,$irrespective$of$the$age$of$implantees$at$surgery.$
National MOH CI Programme: 5-Year Report 2009-2013|ms 35#
.##
CHAPTER 6
SUMMARY
&
RECOMMENDATIONS
Summary'
1. The$ MOH$ Cochlear$ Implant$ Programme$ has$ been$ a$ successful$ programme.$
The$ Medical$ Development$ Division,$ MOH$ has$ taken$ the$ right$ course$ and$
direction$to$implement$the$Cochlear$Implant$Programme$in$ministry$of$health$
hospitals.$
2. $The$surgical$procedures$have$been$shown$to$be$safe$with$successful$cochlear$
implantation$and$low$complications$rate$of$4.3%.$
3. The$ majority$ of$ implantees$ have$ significantly$ gained$ improvement$ in$
auditory$and$speech$performance.$$
$
In$prelingual$implantees,$64.7%$of$them$had$improvement$of$the$mean$aided$
threshold$ of$ better$ than$ 40$ dBHL.$ About$ 78%$ were$ able$ to$ discriminate$
speech$sounds$without$lip$reading$at$24$months$(CAP$score$4$and$above)$and$
71.1%$were$able$to$produce$intelligible$speech$in$single$words$when$context$
and$lip$reading$cues$are$available$(SIR$score$2$and$above).$
In$ the$ postlingual$ implantees$ group,$ following$ implantation,$ 82.1%$ patients$
had$improvement$of$the$mean$aided$threshold$of$better$than$40$dBHL.$At$24$
months$ post$ implant,$ 96.4%$ of$ our$ implantees$ were$ able$ to$ understand$
common$phrases$without$lip$reading$(CAP$score$5$and$above).$
4. In$ the$ prelingual$ group,$ children$ implanted$ at$ younger$ age$ showed$ better$
auditory$ and$ speech$ performance,$ and$ hence$ the$ need$ of$ early$ detection$ of$
hearing$loss$in$neonates.$
5. Postlingual$ and$ cross@over$ implantees$ require$ a$ shorter$ duration$ of$
rehabilitation$period$to$achieve$targeted$auditory$performance.$
6. Children$ without$ behavioral$ issues$ who$ are$ compliant$ to$ cochlear$ implant$
usage$show$better$outcomes.$
7. Participation$ of$ family$ members$ in$ providing$ appropriate$ audiological$ and$
language$ rehabilitation$ is$ vital$ for$ successful$ outcome.$ It$ is$ important$ that$
they$ are$ fully$ involved$ and$ committed$ in$ providing$ adequate$ auditory$ and$
speech$input$to$the$implanted$child.
National MOH CI Programme: 5-Year Report 2009-2013|ms 37#
Recommendations'
Based$ on$ this$ outcome$ review,$ the$ followings$ are$ our$ recommendations$ to$ improve$
and$maintain$successful$outcomes$leading$to$enrolment$of$the$prelingual$implantees$
into$mainstream$schooling:$
1. To$ strengthen$ and$ to$ expand$ the$ Universal$ Neonatal$ Hearing$ Screening$ program$
throughout$the$MOH$facilities$to$allow$early$detection$and$hearing$intervention$in$
the$prelingual$hearing$impaired$children.$
2. To$ address$ the$ contributing$ factors$ to$ poor$ outcome$ that$ affect$ speech$ and$
language$performance$among$the$implantees.$
3. Staffing:$ Adequate$ numbers$ of$ personnel$ in$ the$ satellite$ hospitals$ which$ include$
Surgeons,$ Audiologists,$ Speech$ Therapists$ and$ trained$ paramedics$ to$ ensure$
optimum$service$delivered$to$patient.$$
4. To$ provide$ continuous$ training$ for$ members$ in$ the$ CI$ team$ to$ ensure$ that$ the$
program$is$up$to$date$and$conform$to$international$standards$of$practice.$$
5. To$create$awareness$of$hearing$loss$and$importance$of$early$intervention$among$
all$levels$of$health$care$workers$and$public$at$large.$
6. To$ create$ awareness$ and$ to$ stress$ the$ importance$ of$ parental$ commitment$ in$
home@based$program$to$maximize$rehabilitation$outcome.$
7. To$support$the$initiation$of$early$intervention$centre$for$hearing$impaired$children$
in$Malaysia$in$order$to$promote$oral$and$aural$method$of$communication.$
8. To$expedite$hearing$aid$acquisition$in$order$to$reduce$the$waiting$time$for$hearing$
aid$provision$and$cochlear$implantation,$especially$in$the$prelingual$age$group.$
9. To$ensure$a$consistent$cochlear$implant$grant$from$MOH$in$maintaining$continuity$
of$the$Cochlear$Implant$Program.$
10. To$ develop$ a$ suitable$ national$ assessment$ tool$ in$ audiological$ and$ speech$
outcomes$according$to$the$needs$of$the$local$population.$$
11. To$collaborate$with$other$agencies$in$relation$to$cochlear$implantation$research.$$
National MOH CI Programme: 5-Year Report 2009-2013|ms 38#
Plan'Of'Action'
1. Universal$ Neonatal$ Hearing$ Screening$ Program$ (UNHS)–$ to$ implement$ in$ all$
cochlear$implant$satellite$hospitals$within$two$years$and$five$years$for$others.$
2. Improve$ workflow$ process$ at$ satellite/local$ centers$ to$ expedite$ candidacy$
selection.$
3. To$conduct$road$shows,$regular$workshops$and$continuous$medical$education$
(CME)$to$improve$awareness$and$knowledge$among$primary$care$physicians,$
pediatricians,$other$health$care$professionals,$NGOs$and$public$for$purpose$of$
early$referrals$of$suspected$hearing$loss$cases.$
4. Provision$ of$ training$ to$ all$ categories$ of$ personnel$ involved$ in$ Cochlear$
Implant$Programme$on$yearly$basis.$
5. To$establish$Parent$Support$Groups$in$all$satellite$hospitals$and$to$strengthen$
their$roles$in$order$to$improve$parents$understanding$and$commitment$in$the$
rehabilitation$process$in$two$years$time.$
6. To$ establish$ multidisciplinary$ early$ intervention$ centres$ in$ all$ satellite$
hospitals$for$children$with$hearing$and$speech/language$problems$within$the$
next$five$years.$
7. To$expedite$hearing$aids$acquisition$for$prelingual$(less$than$4$years$old)$and$
postlingual$ deaf$ children$ through$ networking$ with$ funding$ agencies$ e.g.$
Tabung$ Bantuan$ Perubatan$ (TBP)$ and$ Jabatan$ Perkhidmatan$ Awam$ (JPA)$ or$
other$sources$to$fast@track$approval$for$application$of$hearing$aids.$
$
National MOH CI Programme: 5-Year Report 2009-2013|ms 39#
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