Phonak Behind-The-Ear Quality Evaluation

Study Overview
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Brief Summary
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Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.

Detailed Description
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Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.

Official Title
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Phonak Behind-The-Ear Quality Evaluation

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: Phonak Naida BTE hearing aid
* Device: Phonak Naida legacy BTE hearing aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB) 18+ years old Good written and spoken English language skills Able to fill in a questionnaire conscientiously Experienced hearing aid user Able to produce a reliable hearing test result Able to describe listening impressions/experiences and the use of the hearing aids Exclusion Criteria: Not willing to test the hearing aids Has auricle deformities that prevents secure placement of the hearing aids Has limited mobility and is not able to attend the appointments Not willing to wear the hearing aids for at least 8 hours per day Known hypersensitivity or allergy with synthetic materials Self reports symptoms of vertigo, dizziness, fluctuating hearing loss Hints of psychological problems Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This investigation model is a cross-over design, randomized, and is single-blinded.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New BTE hearing aid first, then legacy BTE hearing aid<br>All participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid. | Device: Phonak Naida BTE hearing aid<br>* Newest generation of ultra-power Phonak BTE hearing aids<br>Device: Phonak Naida legacy BTE hearing aid<br>* Previous model/generation of the Naida BTE hearing aid<br>|
| Experimental: Legacy BTE hearing aid first, then new BTE hearing aid<br>All participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid. | Device: Phonak Naida BTE hearing aid<br>* Newest generation of ultra-power Phonak BTE hearing aids<br>Device: Phonak Naida legacy BTE hearing aid<br>* Previous model/generation of the Naida BTE hearing aid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech in Noise Test | Sentences are presented to either the left or right side of the participant's head through a speaker that is 1 meter away. Background noise is presented through the remaining seven speakers that are arranged in a circular pattern around the participant. The sentences are presented at varying levels which may be both louder and softer than the fixed level of noise. The SNR50 is the Signal to Noise Ratio (SNR) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3 dB louder than the noise. Lower SNR50 scores indicate better performance. | Day 14 of the study | 
| Subjective measure of listening effort | A rating scale will be given to the participants following the Speech in Noise Test in which they will rate their perceived listening effort during the test. | Day 14 of the study |