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

NCT03728907 | Withdrawn

• 1 other identifier: 2183099
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

hearing aid; self-fitting

Outcome Measures

Primary Outcomes (1)

• Real-ear aided output

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

  two weeks

Secondary Outcomes (2)

• Device Oriented Scale of Improvement (DOSO)

  two weeks

• Computerized Assisted Speech Perception Assessment (CASPA)

  two weeks

Study Arms (2)

Audiologist-adjusted first

ACTIVE COMPARATOR

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

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

User-adjusted first

EXPERIMENTAL

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

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

Interventions

Hearing aid fitting technique- audiologist or user-adjusted DEVICE

See information under 'arm' description

Audiologist-adjusted first; User-adjusted first

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz
• English speaking

You may not qualify if:

• Score less than 21 on the MoCa (Montreal Cognitive Assessment)
• Evidence of conductive or retrocochlear pathology

Sponsors & Collaborators

• San Diego State University: lead
• University of California, San Diego: collaborator

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and participants will not be aware of which hearing setting (audiologist adjusted vs. self-adjusted) they are wearing
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Repeated-measures crossover design

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: August 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share