A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification

Study Overview
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Brief Summary
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Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the audiologist fitting technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is user-adjustment of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.

Official Title
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A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Hearing aid fitting technique- audiologist or user-adjusted


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz English speaking Exclusion Criteria: Score less than 21 on the MoCa (Montreal Cognitive Assessment) Evidence of conductive or retrocochlear pathology

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 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
Interventional Model Description: Repeated-measures crossover design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Audiologist-adjusted first<br>This arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting. | Device: Hearing aid fitting technique- audiologist or user-adjusted<br>* See information under 'arm' description<br>|
| Experimental: User-adjusted first<br>This arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting. | Device: Hearing aid fitting technique- audiologist or user-adjusted<br>* See information under 'arm' description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-ear aided output | aided output (in dB SPL) measured across frequencies in the ears of the participants | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Oriented Scale of Improvement (DOSO) | Questionnaire (25 items) to assess benefit from hearing aids on a 7 pt scale; a larger number is associated with better outcome | two weeks | 
| Computerized Assisted Speech Perception Assessment (CASPA) | Speech recognition test; phoneme recognition score as percentage correct | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing aid, self-fitting