Investigating Hearing Aid Frequency Response Curves 2

Study Overview
=================
Brief Summary
-----------------
Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. Based on the conclusions of the first study, we have identified areas that require further analysis and testing prior to implementing of the proposed frequency response curve into our products. 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
-----------------
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 and listener comfort. 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 and while in different listening enviroments.

Official Title
-----------------
Investigating Hearing Aid Frequency Response Curves 2

Conditions
-----------------
Hearing Loss, Sensorineural, Hearing Loss, Bilateral

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: N3 - N5 Hearing losses Healthy 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 days Willingness to wear different styles of couplings Willingness to wear binaural fitting Experienced Users = more than 3 months of hearing aid experience Ability to travel to Sonova facilities 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
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound Quality Ratings - Listening Comfort | Participants will be asked to wear hearing aids and as they are exposed to various listening environments. They will be asked to toggle between the two hearing aid programs and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. Reasonings for why ratings were made will also be noted. | 30 Minutes | 
| Sound Quality Ratings - Overall Preference | Participants will be asked to wear hearing aids and as they are exposed to various listening environments. They will be asked to toggle between the two hearing aid programs and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. Reasonings for why ratings were made will also be noted. | 30 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Reception Threshold (SRT) Scores | Participant's SRT scores will be measured under the current freqency response curve and the proposed frequency response curve. They will also be tested without any hearing aids on. Scores will differ based on each participant's hearing loss. Higher scores indicate poorer performance whereas lower scores indicate better performance in noisy situations. The test will be admistered to ensure that participants are able to achieve the same or better SRT scores with the proposed frequency response curve when compared to our current frequency response curve. | 30 Minutes | 

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