Neuromonics Stage 2 Transition Follow-Up Call Post-Fit Form Needed for Courtesy Call Patient Record: Transition FollowUp Form (~10 wks Post Fit) ~ 10 Weeks (Record on Transition Follow-Up Form) To assess how the patient is adjusting after transition. It is important to remind the patient that the purpose of Stage Two of treatment is to gradually expose them to more of the tinnitus by reducing the level of treatment interaction. Patients may need an additional follow-up appointment to receive extra support while they are adjusting to using the treatment and not receiving a high level of tinnitus relief as they did in Stage One. Review Patient’s initial response to Stage Two: Is the treatment Comfortable Yes No (Why?) Level of interaction with treatment and tinnitus? Low Moderate At this prescribed interaction level do you feel Satisfactory Unsatisfactory that you are High achieving relief from the tinnitus? Forms & Items Needed at this Appointment Patient Record: Stage Two Tab Forms Questions or comments? Extra follow-up appointment or phone call? Yes Stage Two follow-up appointment (~ 16 weeks) Date: Stage 2 Appointment Date:__________ ____ ~ 16 Weeks Post-Fit (Record on Stage Two Form ) Computer with Neuromonics NeuroFit Software and NOAH 4 USB cable Patient Oasis Device 1. Tinnitus Reaction Questionnaire (TRQ) - Complete and review Determine % Awareness: Over the past week, what percentage of the time were you aware of your tinnitus? Determine % Disturbance: During the time that you were aware of your tinnitus, what percentage of that time was it bothersome? 2. Broadband Minimum Masking Level Only to be conducted if in discussion with the patient and in reviewing the TRQ in- sufficient progress is being made. (See Assessment or Transition Guide for Instructions) 3. Loudness Discomfort Level & Residual Inhibition Only to be conducted if the patient presented with reduced LDLs at the assessment appointment. (See Assessment or Transition Guide for Instructions) 4. View Data Log from patient’s Oasis Device 5. Adjustment of any device features as indicated 6. Monitor and review Treatment Progression 7. Address any questions or concerns Neuromonics Confidential Page 1 of 6 CL10-0010 Rev 2 View Patient Data Log Select patient in NOAH 4 and open NeuroFit by clicking on icon: Reading the Data Log Date: day/mo/year Total Usage Time Time of day: 00 - 24 hrs. military format Average Daily Volume Tracks Click on the settings icon to open the Settings options Phase: I vs. 2 You can select the date from which the data logging will be displayed. This will otherwise default to the date of the first logged information Neuromonics Confidential The appearance of the Legend for each track can be changed by clicking on the Data logging is displayed on the Right Hand Side of the Fitting Module window. Use the slide bars to view the desired time of day and date View Legend for: Date, Total usage time, Time of day, Average daily volume, Tracks, Phase Page 2 of 6 CL10-0010 Rev 2 icon Tips to Evaluating the Data Log Stage Two Designed to desensitize the patient to tinnitus using intermittent interaction with the tinnitus signal Fostering Desensitization Recommended strategies if desensitization is not occurring: Use “single” setting Reduce volume setting to more moderate interaction Usage Is the patient undergoing treatment a minimum of 2 - 4 hours per day or < 2 hrs per day? During Stage Two, patients are encouraged to use the device consistently while starting to decrease overall usage. Discuss days without usage or <2 hours/day. If the patient occasionally misses a day of use or achieves < 2 hrs per day, that can be a positive sign towards desensitization. Is the patient using the device too much? Is the patient allowing for breaks between use or, is the patient wearing their device all waking hours? This could interfere with desensitization to the tinnitus. If the patient is using the device at the exact same time each day, verify if that is when their tinnitus is bothersome or when it’s convenient? Volume Is the volume set appropriately? (i.e., intermittent 50/50 interaction with tinnitus) Are there fluctuations in volume use? If volume setting does not vary from day to day (vertical line), is he/she counting clicks? Discuss how the patient is setting their volume. Explore any increasing or decreasing trend in the average volume setting. Decreasing volume may start to be appropriate if tinnitus perception is lowering. Interaction What degree of interaction is the patient achieving during treatment? Low Moderate High Complete What degree of tinnitus relief is the patient experiencing during treatment? Low Moderate High Complete Adjustment of any device features as indicated (Refer to NeuroFit Software User Guide for operation) Feature Reason for Adjustment Adjustment Made Audiometry values Decrease overall usage time. Startup Volume Balance Headphone Selection Track Selection Neuromonics Confidential Page 3 of 6 CL10-0010 Rev 2 Stage Two: Progress, Goals, and Progression Treatment Progress - (record on Stage Two Follow-Up Form) Treatment Milestones Middle of Stage Two Reduction in disturbance from tinnitus even when not using treatment (measurable on TRQ) 1. Discuss when tinnitus most disturbing? 2. Is the patient using the treatment during the most disturbing times? (see Usage Data) Yes 3. How much interaction (blending) is the patient achieving at a comfortable listening level? Low Moderate High Complete 4. How much tinnitus relief is the patient achieving when using the treatment? Low Moderate High Complete Review & Discuss Treatment Goals Improvement in tolerance of sounds the patient previously found uncomfortable (measurable on LDLs) N/A Not at All No (action taken) Small Amt Mod Amt 5. Does the patient feel that the treatment has improved his/her ability to relax? 6. Does the patient feel that the treatment has improved his/her ability to sleep? 7. Does the patient feel that the treatment has improved his/her ability to concentrate? End of Stage Two Reduction in awareness from tinnitus even when not using treatment Ceases need to use their device on a regular basis. 8. Does the patient feel he/she has some control over the tinnitus? 9. Is the patient able to ‘set & forget’ treatment? 10. Note progress toward To aid in maintaining long- term benefit or if tinnitus symptoms flare up, the patient may continue to use treatment intermittently with positive relaxation benefits Neuromonics Confidential customized goals 11. Does the patient feel that the treatment is meeting his/her expectations? Page 4 of 6 CL10-0010 Rev 2 Large Amt Treatment Progress continued: 12. Is the patient using the treatment at the appropriate YES NO (why) YES NO (why) YES NO (why) intermittent interaction level (50/50 blending) and achieving appropriate relief? 13. Has the patient been using the treatment for the required 2-4 hours a day? 14. Is the patient experiencing days when they forget to use the treatment? Reintroduction of Pleasurable activities into the Patient’s lifestyle 15. Has there been an improvement in the TRQ? 16. Is there an improvement in the awareness and No Change TRQ TRQ Decreased Increased YES NO (why) YES NO (why) disturbance percentages? (see TRQ form) Often people give up hobbies or other social activities because of the disturbance associated with their tinnitus As this reduces over time with treatment, it can be useful to ask the patient to think about the sort of activities he/she can resume or perhaps initiate, and encourage him/her to start making the first steps. This can also help move the patient’s focus in a positive way to a future that is not restricted by tinnitus. To help make these proposed activities concrete and increase motivation, the clinician can collaborate with the patient to devise an action plan. 17. Is the patient experiencing periods of silence when not using the treatment? 18. From the above responses is there evidence YES NO (why) of desensitization occurring? If No: Recommendations to promote desensitization • Confirm the volume setting is allowing for intermittent interaction (50/50 blending) • Use “single” setting • Remind patient to only reach for device when tinnitus is bothersome. • Recommend decreasing overall regular usage (<2-4 hrs/day and may occasionally skip days Troubleshooting Tips Is the patient setting the volume appropriately? The volume should be set for intermittent 50/50 interaction with their tinnitus. Try to “set and forget”. Set the volume at the beginning of a listening session and then let the music and their tinnitus move into the background of the consciousness. The patient should never set the volume at a level that is uncomfortable. Is the patient listening in to the treatment too much or too little? During non-sleep periods, the device should ideally be used while doing an activity, such as, reading, writing, working on the computer, leisure walking, etc. Ideally, the patient uses the device 2-4 hours per day, but may begin to have days with less usage at during treatment as desensitization begins. Has the patient had a period of acute stress? A stressful period can increase tinnitus levels despite ongoing treatment. Reinforce that the device can be used to help at these times, and continual use over the long term will help the patient better deal with other stressful incidents. Has the patient had excessive noise exposure lately? A period of noise exposure to a concert, wedding, machinery, sporting events, etc., can aggravate tinnitus. If the noise is so loud that the patient needs to shout to be heard, then s/he should consider using hearing protection Does the patient use hearing protection / earplugs? Hearing protection should not be worn at times when there is no significant noise. If s/he can hear the tinnitus over the ambient noise levels, then s/he might be over-using hearing protection Has the patient recently had changes in their overall health? A cold, flu, allergy, eustachian tube dysfunction, excessive ear wax, etc. can enhance tinnitus. Also, changes in medication or dosage may also affect tinnitus. If a change is medication is suspected, refer the patient back to his/her practitioner. Has the patient had extended periods of straining to hear clearly? Extended exposure to softly spoken children or adults, a conference or meeting can draw attention to auditory system dysfunction, and enhance hearing-loss related neural dysfunction. Neuromonics Confidential Page 5 of 6 CL10-0010 Rev 2 Circumstances to Return to Stage 1 Extreme cases of a patient regressing may require returning to Stage One (Phase 1 stimulus). This is usually evidenced by increased TRQ, Awareness & Disturbance percentage levels, increased MMLs and decreased LDLs. If this occurs, then: Refer to “Tinnitus Getting Worse” protocol in Clinician’s Guidelines or NTT Clinician Counseling Guide for trouble- shooting recommendations. Call Neuromonics Clinical Specialist to discuss. Considerations for returning to Phase 1 stimulus: Significant psychological involvement; as evidenced by TRQ Significant increase in stress levels Patient is unable to obtain necessary relief with Phase 2 stimulus Patient is not managing life well Appointment Notes: Next Steps: NEUROMONICS, INC 8774 YATES DR STE 220 WESTMINSTER, CO 80031 U.S.A. Phone: 1-866-606-3876 Fax: 1-800-858-3031 E-mail: info@neuromonics.com Neuromonics Confidential Page 6 of 6 CL10-0010 Rev 2