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

San Diego State University logo

San Diego State University

Status

Withdrawn

Conditions

Hearing Loss

Treatments

Device: Hearing aid fitting technique- audiologist or user-adjusted

Study type

Interventional

Funder types

Other

Identifiers

NCT03728907
2183099

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

0 participants in 2 patient groups

Audiologist-adjusted first
Active Comparator group
Description:
This arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting.
Treatment:
Device: Hearing aid fitting technique- audiologist or user-adjusted
User-adjusted first
Experimental group
Description:
This arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting.
Treatment:
Device: Hearing aid fitting technique- audiologist or user-adjusted

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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