Hearing Aid Signal Processing Comparative Study

Study Overview
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Brief Summary
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Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument.

Official Title
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A Study to Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: Receiver-in-canal hearing instrument; Manufacturer A
* Device: Receiver-in-canal hearing instrument; Manufacturer B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe sensorineural hearing loss Current hearing aid user Exclusion Criteria: Lack of willingness to wear study devices for approximately one month Inability to travel to study appointments or to complete questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-B-A<br>Participants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A | Device: Receiver-in-canal hearing instrument; Manufacturer A<br>* Commercially available receiver-in-canal hearing instrument from manufacturer A<br>Device: Receiver-in-canal hearing instrument; Manufacturer B<br>* Commercially available receiver-in-canal hearing instrument from manufacturer B<br>|
| Experimental: B-A-B<br>Participants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B | Device: Receiver-in-canal hearing instrument; Manufacturer A<br>* Commercially available receiver-in-canal hearing instrument from manufacturer A<br>Device: Receiver-in-canal hearing instrument; Manufacturer B<br>* Commercially available receiver-in-canal hearing instrument from manufacturer B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | End of home trial 1 (Day 10 of study) | 
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | End of home trial 2 (20 days after study start) | 
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | End of home trial 3 (30 days after study start) | 
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn. | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. . | End of home trial 1 (Day 10 of study) | 
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn. | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. | End of home trial 2 (Day 20 of study) | 
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn. | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. | End of home trial 3 (Day 30 of study) |