Investigating Hearing Aid Frequency Response Curves

Study Overview
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Brief Summary
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Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.

Detailed Description
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Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality. However, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music.

Official Title
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Investigating Hearing Aid Frequency Response Curves

Conditions
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Hearing Loss, Sensorineural, Hearing Loss, Bilateral

Intervention / Treatment
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* Device: Hearing Aid - Standard Curve
* Device: Hearing Aid - Variation #1
* Device: Hearing Aid - Variation #2
* Device: Hearing Aid - Variation #3
* Device: Hearing Aid - Variation #4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: N2 - N4 Hearing losses Health Outer ear no visible congenital or traumatic deformity of the outer ear Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz. Ability to answer questions and repeat sentences No history of problematic tinnitus or pain/discomfort from loud sounds No history of active drainage from the ears in the past 90 daysInformed consent as documented by signature Willingness to wear different styles of couplings Willingness to wear binaural fitting Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them) Ability to travel throughout facility Exclusion Criteria: Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products) Limited mobility/not able to come to the scheduled visit Inability to produce reliable hearing test results History of active drainage from the ear in the previous 90 days Abnormal appearance of the eardrum and ear canal.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Hearing Loss<br>Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions. | Device: Hearing Aid - Standard Curve<br>* Our current hearing aids which will be programmed to our standard frequency response curve.<br>Device: Hearing Aid - Variation #1<br>* Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.<br>Device: Hearing Aid - Variation #2<br>* Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.<br>Device: Hearing Aid - Variation #3<br>* Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.<br>Device: Hearing Aid - Variation #4<br>* Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound Quality Rating - Streamed | Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss. Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound Quality Rating - Live | Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and determine which program they prefer to listen to. Participants will be asked to make ratings in the lab, outdoors, and the cafeteria. Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Highers scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Loss, Hearing Aids, Frequency Response Curves