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Individually-guided Hearing Aid Fitting

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Toolset-directed hearing aid fit
Standard-of-care hearing aid fit
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • sensorineural hearing loss with pure-tone thresholds 25-70 decibels hearing level (dB HL) at octave frequencies between 250 and 4000 Hz, 4 (.5, 1, 2, 3 kHz) frequency pure-tone average (PTA) of ≥ 30 dB HL. Listeners will have symmetrical losses, defined here as a 4-frequency PTA difference between ears ≤ 20 dB HL.

Exclusion Criteria:

  • conductive loss (air-bone gaps > 10 dB at any frequency and/or abnormal immittance) -
  • scoring < 23 on the Montreal Cognitive Assessment
  • Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
  • Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
  • Significant history of otologic or neurologic disorders
  • Non English speaking participants
  • Any clinically significant unstable or progressive medical condition
  • Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard-of-care hearing aid fit

Toolset-directed hearing aid fit

Arm Description

Outcomes

Primary Outcome Measures

Speech intelligibility
Repeat low-context sentences

Secondary Outcome Measures

Post-fitting adjustment visits
Number of times hearing aid adjustments are made post-fitting
Self-ratings of professional competence
We will use a modified set of questions drawn from the Evidence-based Practice Confidence (EPIC) Scale. The full scale has been validated across multiple health disciplines. The clinician rates professional confidence from 0% to 100% in increments of 10%, where 0% indicates the clinician has no confidence in his/her ability (i.e., lowest possible value) and 100% indicates complete confidence in his/her ability (i.e., highest possible value). An example question is: "How confident are you in your ability to continually evaluate the effect of your course of action on your patient's or client's outcomes"?

Full Information

First Posted
November 14, 2017
Last Updated
August 28, 2023
Sponsor
Northwestern University
Collaborators
University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT03345654
Brief Title
Individually-guided Hearing Aid Fitting
Official Title
Characterizing Variability in Hearing Aid Outcomes Among Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
University of Colorado, Boulder

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
This translational project aims to optimize the fitting of hearing aids by development and clinical validation of a toolset that guides signal processing choice based on the individual auditory and cognitive abilities of the patient. The clinical trial portion of the project will validate clinical use of the toolset by comparing a population of patients fit with the toolset to those fit using current standard of care. Data will be collected on patient outcomes, clinical impact (number of visits needed to adjust the hearing aids) and audiologist feedback regarding professional confidence. Clinician feedback will also be collected to refine implementation of the clinical application and improve its usability. It is hypothesized that hearing aid fittings completed using the clinical toolset will result in better patient outcomes, fewer post-fitting visits and a higher level of clinician confidence compared to standard-of-care hearing aid fittings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard-of-care hearing aid fit
Arm Type
Placebo Comparator
Arm Title
Toolset-directed hearing aid fit
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Toolset-directed hearing aid fit
Intervention Description
In the toolset-directed arm, audiogram, age and working memory capacity will be measured and the clinician will then use a touchpad application (an implementation of our individualized prediction programs) to guide hearing aid parameter choices.
Intervention Type
Other
Intervention Name(s)
Standard-of-care hearing aid fit
Intervention Description
In the standard-of-care fit, working memory capacity will not be measured and no touchpad application will be used. The clinician will select the hearing aid signal processing parameters based on his/her own knowledge and clinical experience
Primary Outcome Measure Information:
Title
Speech intelligibility
Description
Repeat low-context sentences
Time Frame
Final hearing aid appointment (typically 30-60 days post initial fitting)
Secondary Outcome Measure Information:
Title
Post-fitting adjustment visits
Description
Number of times hearing aid adjustments are made post-fitting
Time Frame
1 year after initial fitting
Title
Self-ratings of professional competence
Description
We will use a modified set of questions drawn from the Evidence-based Practice Confidence (EPIC) Scale. The full scale has been validated across multiple health disciplines. The clinician rates professional confidence from 0% to 100% in increments of 10%, where 0% indicates the clinician has no confidence in his/her ability (i.e., lowest possible value) and 100% indicates complete confidence in his/her ability (i.e., highest possible value). An example question is: "How confident are you in your ability to continually evaluate the effect of your course of action on your patient's or client's outcomes"?
Time Frame
60 days after initial fitting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: sensorineural hearing loss with pure-tone thresholds 25-70 decibels hearing level (dB HL) at octave frequencies between 250 and 4000 Hz, 4 (.5, 1, 2, 3 kHz) frequency pure-tone average (PTA) of ≥ 30 dB HL. Listeners will have symmetrical losses, defined here as a 4-frequency PTA difference between ears ≤ 20 dB HL. Exclusion Criteria: conductive loss (air-bone gaps > 10 dB at any frequency and/or abnormal immittance) - scoring < 23 on the Montreal Cognitive Assessment Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss) Hearing loss remediated with a cochlear implant (cannot wear hearing aids) Significant history of otologic or neurologic disorders Non English speaking participants Any clinically significant unstable or progressive medical condition Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Souza, PhD
Phone
847-491-2433
Email
p-souza@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kendra Marks, AuD
Phone
847-467-0897
Email
kendra.marks@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Marks, AuD
Phone
847-467-0897
Email
kendra.marks@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Individually-guided Hearing Aid Fitting

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