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

Primary Purpose

Hearing Loss

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hearing aid fitting technique- audiologist or user-adjusted
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring hearing aid, self-fitting

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Audiologist-adjusted first

    User-adjusted first

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 31, 2018
    Last Updated
    June 3, 2021
    Sponsor
    San Diego State University
    Collaborators
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03728907
    Brief Title
    A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
    Official Title
    A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We did not receive the equipment from our subcontractor in a time frame that would allow us to complete the study.
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    May 31, 2022 (Anticipated)
    Study Completion Date
    May 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    San Diego State University
    Collaborators
    University of California, San Diego

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss
    Keywords
    hearing aid, self-fitting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Repeated-measures crossover design
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Outcomes assessors and participants will not be aware of which hearing setting (audiologist adjusted vs. self-adjusted) they are wearing
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Audiologist-adjusted first
    Arm Type
    Active Comparator
    Arm Description
    This arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting.
    Arm Title
    User-adjusted first
    Arm Type
    Experimental
    Arm Description
    This arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting.
    Intervention Type
    Device
    Intervention Name(s)
    Hearing aid fitting technique- audiologist or user-adjusted
    Intervention Description
    See information under 'arm' description
    Primary Outcome Measure Information:
    Title
    Real-ear aided output
    Description
    aided output (in dB SPL) measured across frequencies in the ears of the participants
    Time Frame
    two weeks
    Secondary Outcome Measure Information:
    Title
    Device Oriented Scale of Improvement (DOSO)
    Description
    Questionnaire (25 items) to assess benefit from hearing aids on a 7 pt scale; a larger number is associated with better outcome
    Time Frame
    two weeks
    Title
    Computerized Assisted Speech Perception Assessment (CASPA)
    Description
    Speech recognition test; phoneme recognition score as percentage correct
    Time Frame
    two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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