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

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ClinicalTrials.gov Identifier: NCT03728907
Recruitment Status : Withdrawn (We did not receive the equipment from our subcontractor in a time frame that would allow us to complete the study.)
First Posted : November 2, 2018
Last Update Posted : June 8, 2021
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Carol L Mackersie, 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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Hearing aid fitting technique- audiologist or user-adjusted Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Repeated-measures crossover design
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Outcomes assessors and participants will not be aware of which hearing setting (audiologist adjusted vs. self-adjusted) they are wearing
Primary Purpose: Treatment
Official Title: A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Real-ear aided output [ Time Frame: two weeks ]
    aided output (in dB SPL) measured across frequencies in the ears of the participants


Secondary Outcome Measures :
  1. 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

  2. Computerized Assisted Speech Perception Assessment (CASPA) [ Time Frame: two weeks ]
    Speech recognition test; phoneme recognition score as percentage correct



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Carol L Mackersie, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT03728907    
Other Study ID Numbers: 2183099
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carol L Mackersie, San Diego State University:
hearing aid
self-fitting
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases