Consultation protocol
to guide the
assessment of active
middle ear implants
for moderate to
severe sensorineural
hearing loss
June 2014
Table of Contents
MSAC and PASC ........................................................................................................................ 3
Purpose of this document ........................................................................................................... 3
Purpose of application ............................................................................................................. 4
Background .............................................................................................................................. 4
Patient population ...................................................................................................................... 4
Current arrangements for public reimbursement........................................................................... 4
Regulatory status ....................................................................................................................... 5
Intervention ............................................................................................................................. 5
Description................................................................................................................................. 5
Delivery of the intervention ......................................................................................................... 8
Prerequisites .............................................................................................................................. 8
Co-administered and associated interventions .............................................................................. 8
Listing proposed and options for MSAC consideration ............................................................ 8
Proposed MBS listing .................................................................................................................. 8
Clinical place for proposed intervention ........................................................................................ 9
Comparator ............................................................................................................................10
Clinical claim ..........................................................................................................................10
Outcomes and health care resources affected by introduction of proposed
intervention ..............................................................................................................11
Outcomes ................................................................................................................................ 11
Health care resources ............................................................................................................... 12
Proposed structure of economic evaluation (decision-analytic) ...........................................13
Clinical questions ...................................................................................................................13
References .............................................................................................................................14
MSAC and PASC
The Medical Services Advisory Committee (MSAC) is an independent expert committee appointed by
the Australian Government Health Minister to strengthen the role of evidence in health financing
decisions in Australia. MSAC advises the Commonwealth Minister for Health and Ageing on the
evidence relating to the safety, effectiveness, and cost-effectiveness of new and existing medical
technologies and procedures and under what circumstances public funding should be supported.
The Protocol Advisory Sub-Committee (PASC) is a standing sub-committee of MSAC. Its primary
objective is the determination of protocols to guide clinical and economic assessments of medical
interventions proposed for public funding.
Purpose of this document
This document is intended to provide a draft decision analytic protocol that will be used to guide the
assessment of an intervention for a particular population of patients. The draft protocol that will be
finalised after inviting relevant stakeholders to provide input to the protocol. The final protocol will
provide the basis for the assessment of the intervention.
The protocol guiding the assessment of the health intervention has been developed using the widely
accepted “PICO” approach. The PICO approach involves a clear articulation of the following aspects of
the research question that the assessment is intended to answer:
Patients – specification of the characteristics of the patients in whom the intervention is to be
considered for use;
Intervention – specification of the proposed intervention
Comparator – specification of the therapy most likely to be replaced by the proposed
intervention
Outcomes – specification of the health outcomes and the healthcare resources likely to be
affected by the introduction of the proposed intervention
Purpose of application
A proposal for an application requesting MBS listing of active middle ear implants (MEI) for the
treatment of moderate to severe sensorineural hearing loss (SNHL) was received from MED-EL
Implant Systems Australia Pty Ltd by the Department of Health and Ageing in September 2013. The
proposal is for a new intervention on the MBS.
Background
A previous application for MBS listing of active middle ear implants for the treatment of SNHL (as well
as conductive (CHL) and mixed (MHL)) hearing loss was considered by MSAC in July 2010
(Application 1137). MSAC did not support funding. A new applicant is responsible for the current
application.
The population identified with the previous application was patients with mild, moderate or severe
SNHL, who have failed all other conservative medical, pharmaceutical and behavioural treatments.
The comparators that were considered appropriate were bone anchored hearing aids (BAHA) for mild
or moderate SNHL and cochlear implants (CI) for severe SNHL.
MSAC rejected the application on a number of grounds:

There was a lack of data on long term safety of MEI;

There were no comparative studies of MEI versus BAHA, and therefore MSAC could not
conclude that MEI is more effective than BAHA in any patient group;

There was only one comparative study of MEI versus CI, and this suggested that MEI may be
less effective than CI;

A cost comparison indicated that MEI was more expensive than BAHA, but less expensive
than CI. MSAC considered that in patients for whom BAHA is suitable, MEI would be a more
expensive option, but with no evidence of improved hearing to justify the extra expense. In
patients for whom CI is suitable, MEI would be cheaper, but on the available evidence, may
be less effective.

MSAC was unable to identify any particular subgroup of patients who, after failure of hearing
aids and other conservative treatment, would be suitable for MEI.
Patient population
The PASC has agreed that the population relevant to the current application are patients with
moderate or severe SNHL who have failed all other conservative treatments.
Current arrangements for public reimbursement
The implantation procedure is performed in public and private hospitals throughout Australia and may
be funded by public hospital surgical budgets, private health fund ex-gratia payments and
occasionally is self-funded by patients. The implantation procedure is not funded through the MBS
and the device is not listed on the Prosthesis List (PL).
Regulatory status
The applicant, MED-EL Implant Systems Australia Pty Ltd, is the sponsor of the following MEI
components, which are registered for use in Australia. The Vibrant Soundbridge system (VSB) is the
only MEI currently registered for use in Australia.
Table 1: MEI components listed on the ARTG
ARTG No
170179
Product
Indication
Amade audio processor -
The Amade audio processor is an external part of the Vibrant
Middle
Soundbridge system. The Vibrant Soundbridge system is indicated for
ear
implant
system sound processor
use in patients who have mild to severe hearing impairment and
cannot achieve success or adequate benefit from traditional therapy.
161702
185533
Vibrating Ossicular
For use in adults, adolescents and children who have mild to severe
Prosthesis (VORP) 502X -
hearing impairment and cannot achieve success or adequate benefit
Hearing aid, middle ear
from traditional therapy. For sensorineural HL, the VORP is crimped to
implant.
the long process of the incus to directly drive the ossicular chain.
Vibroplasty
Coupler
-
The Vibroplasty Couplers are intended to be used in combination with
Hearing aid, middle ear
the Vibrant Soundbridge to facilitate the coupling between the FMT
implant.
and a Vibratory Structure of the middle ear. The prosthesis type is
chosen on the basis of the ossicular remnants once all primary disease
has been removed from the middle ear.
Intervention
Description
Hearing and hearing loss
The function of the ear is to convert sound waves occurring in the environment into electrical
impulses that can be interpreted by the brain. The ear is comprised of three parts - outer, middle and
inner. The outer ear consists of the pinna, the external auditory canal and the tympanic membrane.
The pinnae funnel sound waves into the external auditory canal resulting in increased sound wave
pressure levels at the tympanic membrane. The resulting vibration of the membrane is transmitted to
the auditory ossicles (the malleus, incus and stapes) that are contained within the air-filled middle
ear. The footplate of the stapes is connected to the oval window, through which vibration of the
ossicles is transmitted into the fluid-filled cochlea of the inner ear. Vibration of the fluid within the
cochlea results in stimulation of the hair cells of the organ of Corti. This stimulation results in the
generation of action potentials and the transmission of electrical impulses to the brain via the
cochlear nerve.
Figure 1: External, middle and inner ear (Application 1137)
The transmission of sound
via the external auditory
canal and middle ear to the
fluid of the inner ear is
referred to as air conduction.
Sound can also be
transmitted to the fluid of
the inner ear via bone (bone
conduction), if the sound
source is applied directly to
the bones of the skull.
The intensity of sound is
measured using the decibel
(dB) scale. The threshold of
hearing is defined as the
minimum effective sound pressure of a signal that is capable of provoking an auditory sensation
(Keith 2002). Normal hearing thresholds are between 0 and 24 db. The severity of hearing loss is
categorised as follows (Kulkarni and Hartley 2008):
Table 2: Levels of hearing loss
Hearing threshold (dB)
Interpretation
0-24
Normal hearing
25-39
Mild hearing loss
40-69
Moderate hearing loss
70-94
Severe hearing loss
≥95
Profound hearing loss
Hearing loss is classified as being conductive, sensorineural or mixed. Conductive hearing loss arises
from an inability of the ear to conduct sound energy to the inner ear. It may be caused by lesions in
the outer or middle ear. Sensorineural hearing loss results from any dysfunction of the hair cells in
the inner ear or the cochlear nerve. Mixed hearing loss occurs when both CHL and SNHL are present
in the same ear (Kesser and Friedman 2002). There are multiple potential causes of both CHL and
SNHL with the type of hearing loss determined using audiometry.
Prevalence in Australia
Overall hearing loss prevalence in Australia is reported as 22.2% (Application). Sensorineural hearing
loss is the most common form of hearing loss in Australia. The overall prevalence in adults, based on
a South Australian study, is 20.5% for SNHL, 0.4% for CHL and 1.5% for MHL (Table 3, Wilson et al
1998).
In adults (>15 years), SNHL is largely caused by ageing with most people with SNHL
aged >50 years. It may also be related to exposure to noise or ototoxic substances. There are more
adult males with hearing loss than females (26.3%% males vs 17.1% females). In adults, 66% have
mild HL; 23% have moderate HL and 11% have severe to profound HL.
Table 3: Prevalence of hearing impairment (worse ear) South Australian population
Age
SNHL
CHL
MHL
≧ 25dBHTL
≧ 25dBHTL
≧ 25dBHTL
15-50 yrs
4.2 (0.0-8.3)
0.3 (0.1-0.5)
0.7 (0.1-0.4)
51-60 yrs
26.3 (11.5-41.1)
0.4 (0.0-1.1)
1.6 (0.2-3.0)
61-70 yrs
55.2 (37.0-73.3)
0.0
3.6 (1.9-5.3)
>70 yrs
69.4 (42.2-96.6)
0.0
4.1 (0.0-10.6)
Total
20.5 (15.1-25.9)
0.4 (0.0-0.5)
1.5 (0.9-2.1)
The overall prevalence of hearing loss in children (<15 years) is 2.5 in 1,000. Of these, 36.7% have
mild hearing loss; 38.3% have moderate hearing loss, 13.3% have severe hearing loss and 11.7%
have profound hearing loss.
Sensorineural hearing loss in children may be caused by genetics,
maternal infection, birthing issues or childhood infections such as meningitis.
Certain population groups such as communities of Aboriginal or Torres Strait Islander people have a
significantly higher prevalence of ear disease and hearing loss. For example, the rate of hearing loss
in Aboriginal children is estimated at between 10% and 41%.
Based on the adult SNHL prevalence rates in Table 3, and using December 2013 population data,
approximately 1,043,438 Australian adults at December 2013 would be affected by SNHL. Of these,

689,000 would have mild SNHL;

240,000 would have moderate SNHL; and

115,000 would have severe to profound SNHL (rounded to nearest 1,000).
It is unclear what proportion of people with SNHL would meet the criteria set out for this application.
The procedure
MEIs are either fully or partially implantable hearing devices.
Figure 2 Vibrant Soundbridge MEI
A microphone in the device detects sounds,
and a processor changes the sounds to
electrical impulses. The electrical impulses
are then converted to mechanical vibrations
by a component of the device that is directly
attached to the ossicular chain or round
window in the middle ear.
A diagram of the VSB, which is a partially
implantable device, is at Figure 2.
There are other MEIs aside from the Vibrant Soundbridge system which have been trialed or
approved for use in other countries. The proposed MBS listing relates to MEIs in general, and not
specifically to products registered in Australia.
Delivery of the intervention
The implantation procedure is a one-off intervention. According to the applicant, an overall rate of
revision surgery of 7% is reported in the literature.
Prerequisites
Specialist ear nose and throat (ENT) surgeons would deliver the implantation procedure. Expert
colleagues, supported by the device manufacturer, would train surgeons.
The procedure is
performed in hospital, either as day surgery or in the inpatient setting with an overnight stay. The
duration of the procedure is approximately 1.0 to 2.5 hours.
Co-administered and associated interventions
A pre-surgical consultation with the ENT surgeon would be required. The procedure may be
performed under either a local or a general anaesthetic. If the surgery is performed under a general
anaesthetic a specialist anaesthetist would be required.
Following surgery, an outpatient consultation (45 minutes) with an audiologist is required for
assessment and fitting and programming of the device processor. A further follow-up consultation (30
minutes) is required 1 month later.
Listing proposed and options for MSAC consideration
Proposed MBS listing
The details of the MBS listing agreed by PASC are shown in Table 4: Proposed MBS item descriptor
for MIDDLE EAR IMPLANT, Insertion of, including a mastoidectomy
Table 4: Proposed MBS item descriptor for MIDDLE EAR IMPLANT, Insertion of, including a mastoidectomy
Category 3 – Therapeutic Procedures
MBS [item number]
MIDDLE EAR IMPLANT, Insertion of, including a mastoidectomy, for patients who have:
-
have sensorineural hearing loss that is stable, bilateral and symmetrical; and
air conduction thresholds in the moderate to severe range with PTA4 below 80 dB HL; and
have speech perception discrimination of at least 65% correct with appropriately amplified sound; and
cannot wear conventional hearing aid because of a medical reason affecting the outer ear; and
no history of inner ear disorders, such as vertigo or Meniere’s syndrome;
a normal middle ear, with no history of middle ear surgery; no history of post-adolescent, chronic middle ear
infections; normal tympanometry; and on audiometry, the air-bone gap at 0.5, 1, 2 and 4 kHz is no greater than
10 dB HL at two or more of these frequencies.
Fee: $1,876.59 (based on mastoidectomy item).
(Anaes)
Clinical place for proposed intervention
The proposed population for the intervention is:
a.
Patients with stable SNHL that meet the pure tone audiometry (PTA) criteria of:
i.
moderate hearing loss - 40 dB ≤ BEHL0.5–4 kHz < 70 dB;or
ii.
severe hearing loss - 70 dB ≤ BEHL0.5–4 kHz < 95 dB; AND
b.
PTA is less than 80 dB HL; AND
c.
Speech understanding is >65% for word lists with appropriately amplified sound: AND
d.
SNHL is bilateral and symmetrical. PTA thresholds (both ears) are within 20 dB HL of each other
at 0.5 to 4 kHz; AND
e.
SNHL occurs in patients who cannot use conventional hearing aids because of a medical
condition affecting the outer ear; AND
f.
SNHL occurs in patients who have a normal middle ear, with:
i.
no history of middle ear surgery; AND
ii.
no history of post-adolescent, chronic middle ear infections; AND
iii.
normal tympanometry; AND
iv.
on audiometry, the air-bone gap at 0.5, 1, 2 and 4 kHz is no greater than 10 dB HL at
two or more of these frequencies; AND
g.
Patients have no history of inner ear disorders, such as vertigo or Meniere’s syndrome.
The clinical management algorithm proposed by the applicant is shown in
Figure 3.
Figure 3 – Clinical management algorithm
Comparator
The PASC has agreed that the appropriate comparators are:

BAHA compared to MEI for moderate SNHL;

CI compared to MEI for severe SNHL.
Clinical claim
The clinical claim for MEI (i.e. the VSB) is superior effectiveness and non-inferior safety, compared to
the comparators (BAHA for moderate HL and CI for severe HL).
Comparative safety
versus comparator
Table 5: Classification of an intervention for determination of economic evaluation to be presented
Comparative effectiveness versus comparator
Superior
Non-inferior
Inferior
Net clinical benefit CEA/CUA
Superior
CEA/CUA
CEA/CUA
Neutral benefit
CEA/CUA*
Net harms
None^
Non-inferior
Inferior
CEA/CUA
Net clinical benefit
Neutral benefit
Net harms
CEA/CUA
CEA/CUA*
None^
CEA/CUA*
None^
None^
None^
Abbreviations: CEA = cost-effectiveness analysis; CUA = cost-utility analysis
* May be reduced to cost-minimisation analysis. Cost-minimisation analysis should only be presented when the proposed service has been indisputably
demonstrated to be no worse than its main comparator(s) in terms of both effectiveness and safety, so the difference between the service and the
appropriate comparator can be reduced to a comparison of costs. In most cases, there will be some uncertainty around such a conclusion (i.e., the
conclusion is often not indisputable). Therefore, when an assessment concludes that an intervention was no worse than a comparator, an assessment
of the uncertainty around this conclusion should be provided by presentation of cost-effectiveness and/or cost-utility analyses.
^ No economic evaluation needs to be presented; MSAC is unlikely to recommend government subsidy of this intervention
Outcomes and health care resources affected by introduction of proposed
intervention
Outcomes
The PASC agreed outcome measures for MEI versus the comparators for effectiveness were:

Abbreviated Profile of Hearing Aid Benefit (APHAB);

Client-orientated scale of improvement;

Functional gain;

Speech recognition;

Real ear insertion gain;

Sound-field assessment;

Speech comprehension scores;

Tympanometric and acoustic reflex measures;

Self-assessment scales/patient preference.
The PASC agreed outcome measures for MEI versus the comparators for safety were:

Complications

Adverse events;

Infection rates;

Taste disturbance;

Fibrosis;

Aural fullness;

Acoustic trauma;

Dizziness;

Damage to the middle ear;

Revision surgery

Explant rate

Device failure;

Mortality.
Health care resources
The health care resources required for MEI, as proposed by the applicant, are shown in Table 6: List
of resources to be considered in the economic analysis.
Table 6: List of resources to be considered in the economic analysis
Setting in Proportion
Provider of
which
of patients
resource resource is receiving
provided
resource
Number of
units of
resource
per relevant
time
horizon per
patient
receiving
resource
Disaggregated unit cost
MBS
Safety
nets*
Other
govt
budget
Private
health
insurer
Patient
Total
cost
Resources provided to identify eligible population
Resources provided to deliver proposed intervention
Prosthesis
Public/
Hospital
Private
health Fund
Pre-assessment
Audiologist Outpatient
audiogram
(ENT)
MBS 82315 (11327)
Impedance audiogram
Audiologist Outpatient
MBS 82327 (11327)
(ENT)
CT scanning
MBS
Outpatient
MBS 56016
ENT consultation
MBS
Outpatient
MBS 104
Anaesthesia prep
Anaesthetist Hospital
MBS17610
Anaesthesia
Anaesthetist Hospital
MBS 20120
Facial stem monitoring
ENT
Hospital
MBS 11015
Implant procedure
ENT
Hospital
Proposed fee based on
current MBS item for
mastoidectomy
Surgical assistant
MBS 51303
Hospital stay
Hospital
Post-op audiometry
Audiologist Outpatient
MBS 82300 (11300)
/ ENT
Resources provided in association with proposed intervention
Follow-up ENT consult
ENT
Outpatient
MBS 105
Fitting of processor
Audiologist Outpatient
MBS 10952
Follow-up audiometry
Audiologist Outpatient
MBS 82300 (11300)
(ENT)
Battery cost
Outpatient
* Include costs relating to both the standard and extended safety net.
1.0
13,970
1.0
33.45
(41.85)
1.0
1.0
13.45
(16.80)
246.50
1.0
72.75
1.0
32.25
1.0
74.25
1.0
112.45
1.0
1876.59
13,970
375.92
TBA
1.0
130.90
(163.60)
36.55
1.0
52.95
1.0
130.90
(163.60)
52.0
Proposed structure of economic evaluation (decision-analytic)
The PICO for comparison of MEI versus the comparators, as agreed by PASC, is shown in Table 7:
Summary of extended PICO to define research question that assessment will investigate.
Table 7: Summary of extended PICO to define research question that assessment will investigate
Patients
Patients with moderate SNHL with:
• stable, bilateral, symmetrical HL; and
• a medical condition in the outer ear and a
normal middle ear; and
• unable to wear or benefit from HAs due to
medical reasons; and
• no previous middle ear surgery; and
• no history of post-adolescent, chronic middle
ear infections or inner ear disorders such as
vertigo or Meniere’s syndrome; and
• unaided speech recognition above 65%.
Intervention
Middle ear
implant
Comparator
Bone anchored
hearing aid
Outcomes to be assessed
Effectiveness outcomes:
- Abbreviated Profile of Hearing Aid Benefit
(APHAB);
- Client-orientated scale of improvement;
- Functional gain;
- Speech recognition;
- Real ear insertion gain;
- Sound-field assessment;
- Speech comprehension scores;
- Tympanometric and acoustic reflex measures;
- Self-assessment scales/patient preference.
Patients with severe SNHL with:
• stable, bilateral, symmetrical HL; and
• a medical condition in the outer ear and a
normal middle ear; and
• unable to wear or benefit from HAs due to
medical reasons; and
• no previous middle ear surgery; and
• no history of post-adolescent, chronic middle
ear infections or inner ear disorders such as
vertigo or Meniere’s syndrome; and
• unaided speech recognition above 65%.
Middle ear
implant
Cochlear implant
Safety outcomes:
- Complications
- Adverse events;
- Infection rates;
- Taste disturbance;
- Fibrosis;
- Aural fullness;
- Acoustic trauma;
- Dizziness;
- Damage to the middle ear;
- Revision surgery
- Explant rate
- Device failure;
- Mortality.
Clinical questions
1. In patients with moderate SNHL is the MEI more effective than the BAHA?
2. In patients with severe SNHL is the MEI more effective than the CI?
3. In patients with moderate SNHL is the MEI as safe as the BAHA?
2. In patients with severe SNHL is the MEI as safe as the CI?
References
Access Economics (2006). Listen Hear! The economic impact and cost of hearing loss in Australia .
Keith RW; Clinical Tests. In: Seiden AM et al (eds) (2002). Otolaryngology: The Essentials. New York:
Thieme, 2002, pp. 13-27.
Kesser BW and Friedman RA; Functional disorders. In: Seiden AM et al (eds). (2002). Otolaryngology:
The Essentials. New York: Thieme, pp. 33-38.
Kulkarni K and Hartley DEH, 2008. ‘Recent advances in hearing restoration’, Journal of the Royal
Society of Medicine, 2008: 101, 116-124.
Perera C, Thavaneswaran P,
Lee I and Church J (2010) Middle ear implant for sensorineural,
conductive and mixed hearing losses Assessment Report for Medical Services Advisory Committee
Application 1137. Commonwealth of Australia.
Seiden AM et al (eds) (2002). Otolaryngology: The Essentials. New York: Thieme.
Wilson D, Walsh PG, Sanchez L, Read P. Hearing impairment in an Australian population.
Centre for Population Studies in Epidemiology, South Australian Department of Human Services.
1998