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

NCT ID: NCT03728907

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-05-31

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Audiologist-adjusted first

This arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting.

Group Type: ACTIVE_COMPARATOR

Hearing aid fitting technique- audiologist or user-adjusted

Intervention Type: DEVICE

See information under 'arm' description

User-adjusted first

This arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting.

Group Type: EXPERIMENTAL

Hearing aid fitting technique- audiologist or user-adjusted

Intervention Type: DEVICE

See information under 'arm' description

Interventions

Hearing aid fitting technique- audiologist or user-adjusted

See information under 'arm' description

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Carol L Mackersie

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2183099

Identifier Type: -

Identifier Source: org_study_id