Overview and Fitting Guide

Overview and Fitting Guide
 Overview and Fitting Guide Neuromonics Sanctuary Fitting Criteria and User Protocol Product Overview Targeting immediate relief for the tinnitus patient with a TRQ score of 35 or below, the Sanctuary™ is designed to provide relief for patients while listening to the device. Incorporating a Phase One Neuromonics Stimulus, the Sanctuary™ provides a sense of control by delivering a semi-­‐custom signal designed for a maximum level of interaction with the tinnitus perception. This interaction provides an almost immediate sense of control and relief for the tinnitus patient. Patients will be assigned to one of three pre-­‐determined audiometric profiles shown below to determine the best audiometric profile. Neuromonics Phase One Stimulus The Sanctuary is pre-­‐loaded with the Phase One Neuromonics Stimulus. The underlying principle is to provide a high level of interaction for the patient while listening, thus providing an immediate sense of control and relief over the tinnitus perception. Supplemental Materials In addition to the programmed Oasis device, patients will receive supplemental material to help them with tinnitus management strategies. These materials include: •
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www.myneuromonics.com to access troubleshooting tips, treatment overview videos and other tips for success Neuromonics Sanctuary Tinnitus Management Handbook Device Usage •
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Patients are recommended to wear their device when their tinnitus is bothersome. Patients should use the device at a volume that is comfortable while providing the maximum relief from their tinnitus. Patients are advised to turn the volume down in advance of ending a listening session. They should also avoid removing the device in an environment that is quiet. Patients should not use their device when straining to hear, when exercising, while driving, watching television with sound, while wearing a hearing aid or when the device may get wet. Candidacy Candidates for the Neuromonics Sanctuary are individuals with a complaint of tinnitus that are seeking a management program as opposed to a treatment protocol. Ideally this will be someone with a TRQ score of 35 or below. The Neuromonics Sanctuary will use a “semi-­‐custom” version of the Neuromonics Oasis stimulus that is appropriate for one of the three fitting ranges pictured below. You will choose the fitting range that best matches your patient’s audiogram. Neuromonics recommends that approximately 75% of your patient’s audiometric thresholds fall within the fitting range of the specified audiogram. If your patient is outside of a fitting range, then it is left to the clinical judgment of the clinician to choose the most appropriate range. Attention must be paid to adequate stimulation when choosing the most appropriate fitting range. Audiometric Guidelines: Fitting “Profile “1” Fitting Profile “2” Fitting Profile “3” Fitting Profile “1” is for normal hearing, or normal hearing sloping to a mild, high frequency symmetrical hearing loss. Fitting Profile “2” is for normal hearing sloping to a mild through moderately severe, high frequency symmetrical hearing loss. Fitting Profile “3” is for normal hearing /mild hearing loss sloping to a moderately severe through severe, high frequency symmetrical hearing loss. In addition to the hearing profile choices above, patients should meet the following criteria: •
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TRQ score of 35 or below Disturbance and awareness, in general, should be below 50% •
No apparent Psychological Disturbance. •
Patient must score a 0 on TRQ question #24 •
No apparent indication of reactive tinnitus Quality of Life Indicators •
Patients that experience difficulty before bed and during quiet times; such as while reading or working on a computer are good candidates for the Sanctuary. Also, if concentration is a problem this protocol is appropriate. The Sanctuary is designed to provide relief for patients during times when their tinnitus is disturbing and those times while wearing the device. Device Fitting/ Assessment Assessment/ Fitting Appointment: You should continue to use your standard tinnitus assessment including testing for Residual Inhibition to identify potential cases of reactive tinnitus. Given the pre-­‐configured set-­‐up of the Sanctuary, patients can be fit the same day in your office. Topics to cover during the fitting include: o Device Instruction o Expectation counseling o Establish patient goals and appropriate device usage o Review Tinnitus Management Handbook o Determine interaction and relief levels o Provide information regarding www.myneuromonics.com Contained within the device menus are the following items that must be selected: o Headphone choice (default option will be those included with Sanctuary) o Hearing profile selection The above selections are made via the device setup menu. •
Headphone Selection • The Neuromonics Sanctuary will include Sony MDR-­‐ED12LP headphones. The unit will come programmed with this headphone selection. One additional headphone options is also available for the Sanctuary at an additional charge: o Bose IE2 -­‐ $99 Speaker Accessory Available as a bedside accessory to aid in sleep onset, the JBL Micro can be purchased for an additional $49. The Micro connects via a self-­‐contained 3.5mm headphone jack. *If an additional set of headphones is ordered, then the appropriate change must be made in the headphone selection menu when setting up the device. Follow Up Protocol No specific follow up protocol is required for Neuromonics Sanctuary patients. Subsequent office visits are based on the needs of the patient and the discretion of the fitting clinician. If such visits are warranted, particular attention to the following items is suggested: o Make sure patient goals for relief are being met while wearing device. o Review realistic expectations and discuss additional options if patient is not experiencing relief. Summary The Neuromonics Sanctuary is designed to help the mild to moderate tinnitus sufferer experience relief from their tinnitus disturbance while wearing the device. The Sanctuary is not designed to replace the Neuromonics Tinnitus Treatment or to treat the severely disturbed tinnitus patient. The Sanctuary is designed to offer relief and tinnitus management options for your patients. Management expectation, as with all tinnitus treatment options, will be integral to the overall success of the management program. The expectation should be set that patients will typically only experience relief while wearing their Sanctuary device. The management program is centered on a providing situational relief from the tinnitus perception. By using the Sanctuary in specific situations such as going to bed, when reading or in quiet times, the user will gain a sense of control and relief over their tinnitus. As always, please contact your Neuromonics Clinical Specialist if you encounter difficult patients or have any questions regarding the appropriateness of a particular patient. Neuromonics Sanctuary Patient Expectation/ Fitting Agreement
Patient Name _____________________________________ Date __________________________
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Based on your TRQ score of __________, are not considered an appropriate candidate for the
Neuromonics
Sanctuary.
•
Based on your TRQ score of __________, are considered an appropriate candidate for the Neuromonics
Sanctuary.
The Sanctuary is not:
The Sanctuary is:
A tinnitus management tool
A cure for tinnitus
Designed for relief while listening
A long term treatment program
Appropriate for all types of tinnitus
and/or levels of hearing loss
A medical device
I should use the Sanctuary:
I should not use the Sanctuary:
In quiet times
When driving
When my tinnitus is bothersome
While watching TV or straining to hear
While attempting to fall asleep
While exercising
The following conditions can limit the effectiveness of the device:
o
o
o
o
o
Asymmetrical Hearing greater than 20db between ears
Answer other than “0” on TRQ question 24
TRQ score greater than 35
Significant history of depression/anxiety/disturbance associated with your tinnitus
A tinnitus disturbance level requiring a treatment protocol and follow-up program as opposed to a
management tool.
Doc. No CL2-­‐0003 Revision 1 As part of my tinnitus management program I agree to:
Listen to my Sanctuary at the appropriate times and at a comfortable volume level
Take steps to mitigate other factors that negatively impact my tinnitus
Consult my clinician if I feel my tinnitus is worsening
The benefits I can achieve by using the Sanctuary appropriately are:
Control over my tinnitus
Relief while listening
Help with concentration
Help with relaxation
I, _________________________________________________, understand that I am / am not considered a candidate for the
Neuromonics Sanctuary based on the evaluation of my audiologist. As a result I would like to purchase the device in
anticipation of any benefits it may provide.
Patient Signature ___________________________
Date ___________________________________
Doc. No CL2-­‐0003 Revision 1 
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