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

June 3, 2021 updated by: Carol L Mackersie, San Diego State University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Audiologist-adjusted first
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
See information under 'arm' description
Experimental: User-adjusted first
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
See information under 'arm' description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-ear aided output
Time Frame: two weeks
aided output (in dB SPL) measured across frequencies in the ears of the participants
two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Collaborators

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2183099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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