Validation of Novel BTE and SP Hearing Aid Models

Study Overview
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Brief Summary
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Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super power) BTEs.

Detailed Description
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During this study each participant will be asked to wear a set of BTE hearing aids home and wear them daily. We will be assessing their evaluation of the BTEs during and after their home field trial. They will be asked to report on their use with different apps/accessories. Subjective performance ratings will be collected.

Official Title
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Validation of 2 Novel BTE Hearing Aid Models Varying With Respect to Regular-power or Super-power Gain Specifications

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: BTE hearing aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hearing aid candidacy (N2-N7 hearing loss) healthy outer and middle ears ability to complete questionnaires willingness to use smartphone informed consent documented by a signature willingness to wear a binaural BTE fitting willingness to use app and accessories willingness to adhere to COVID protocols Exclusion Criteria: contraindications to the MD in this study: known hypersensitivity or allergy to investigational product/earmold limited mobility/not able to attend appointments limited ability to describe listening impressions/experiences inability to produce a reliable hearing test result limited dexterity - to point that participant cannot manage hearing aid insertion/removal known psychological disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Interventional Model Description: 2 groups based on hearing aid gain needs; one similar intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTE hearing aid model<br>BTE or SP-BTE (super power) hearing aid fitting | Device: BTE hearing aid<br>* Amplification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound Quality | Subjective evaluation of sound quality using Sound Quality Ratings from Gabrielsson et al 1988 (The effects of different frequency responses on sound quality judgments and speech intelligibility. JSHR. Vol.31) | 3-7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Stability | Reports of system stability with accessories and Subjective evaluation of sound quality using Sound Quality Ratings from Gabrielsson et al 1988 (The effects of different frequency responses on sound quality judgments and speech intelligibility. JSHR. Vol.31) | 3-7 weeks | 
| Usability | Reports of app usability/sound quality using Sound Quality Ratings from Gabrielsson et al 1988 (The effects of different frequency responses on sound quality judgments and speech intelligibility. JSHR. Vol.31) | 3-7 weeks |