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

Not Applicable

Withdrawn

• Conditions: Hearing Loss
• Interventions: Device: Hearing aid fitting technique- audiologist or user-adjusted

• Registration Number: NCT03728907
• Lead Sponsor: San Diego State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-08
• Study Start: 2021-08-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Audiologist-adjusted first	Hearing aid fitting technique- audiologist or user-adjusted	This arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting.
User-adjusted first	Hearing aid fitting technique- audiologist or user-adjusted	This arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting.

Primary Outcome Measures

Name	Time	Method
Real-ear aided output	two weeks	aided output (in dB SPL) measured across frequencies in the ears of the participants

Secondary Outcome Measures

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