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We did not receive the equipment from our subcontractor in a time frame that would allow us to complete the study.
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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audiologist-adjusted first | Active Comparator | This arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting. |
|
| User-adjusted first | Experimental | This arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aid fitting technique- audiologist or user-adjusted | Device | See information under 'arm' description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-ear aided output | aided output (in dB SPL) measured across frequencies in the ears of the participants | two weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Repeated-measures crossover design
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Outcomes assessors and participants will not be aware of which hearing setting (audiologist adjusted vs. self-adjusted) they are wearing
Speech recognition test; phoneme recognition score as percentage correct
| two weeks |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |