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Clinical Trials/NCT03728907
NCT03728907
Withdrawn
Not Applicable

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

San Diego State University0 sitesAugust 1, 2021
ConditionsHearing Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
San Diego State University
Primary Endpoint
Real-ear aided output
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
May 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carol L Mackersie

Professor

San Diego State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Real-ear aided output

Time Frame: two weeks

aided output (in dB SPL) measured across frequencies in the ears of the participants

Secondary Outcomes

  • Computerized Assisted Speech Perception Assessment (CASPA)(two weeks)
  • Device Oriented Scale of Improvement (DOSO)(two weeks)

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