Compression Headphone Study

Study Overview
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Brief Summary
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The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. The survey will involve a training session and within-subject repeated measures. Stimuli will be randomized.

Official Title
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Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Receiver-in-canal hearing aid 1 default
* Device: Receiver-in-canal hearing aid 2
* Device: Receiver-in-canal hearing aid 1 strategy 1
* Device: Receiver-in-canal hearing aid 1 strategy 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18-99 years) with ≥3 months hearing aid experience binaural, symmetric, sensorineural N3 to N4 hearing loss able to use Android interface and receive a video call on phone/computer fluent in English Exclusion Criteria: children/teenagers normal hearing or hearing loss exceeding N4 by 10dB cannot wear over-ear headphones

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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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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Receiver-in-canal hearing aid 1 default<br>Receiver-in-canal hearing aid with current default compression strategy | Device: Receiver-in-canal hearing aid 1 default<br>* A receiver-in-canal hearing aid developed by the Study Sponsor used with the default settings as specified in the Study Sponsor's fitting software.<br>|
| Active Comparator: Receiver-in-canal hearing aid 2<br>Receiver-in-canal hearing aid from a different manufacturer with default compression strategy | Device: Receiver-in-canal hearing aid 2<br>* A receiver-in-canal hearing aid developed by another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software.<br>|
| Experimental: Receiver-in-canal hearing aid 1 strategy 1<br>Receiver-in-canal hearing aid with modified compression strategy 1 | Device: Receiver-in-canal hearing aid 1 strategy 1<br>* A receiver-in-canal hearing aid developed by the Study Sponsor used with a modified compression strategy that is expected to improve the sound quality.<br>|
| Experimental: Receiver-in-canal hearing aid 1 strategy 2<br>Receiver-in-canal hearing aid with modified compression strategy 2 | Device: Receiver-in-canal hearing aid 1 strategy 2<br>* A receiver-in-canal hearing aid developed by the Study Sponsor used with a modified compression strategy that is expected to improve the sound quality.<br>|
| No Intervention: No device<br>Stimuli recordings without hearing aid | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound quality rating | The sound quality rating will be conducted via an online questionnaire that contains sound samples participants listen to and rate subsequently. Dimensions rated are: Overall Preference, Reverberation, Sound Source Localization, Sound Source Separation, and Timbral Balance. | 1 hour |