Individually-guided Hearing Aid Fitting

Characterizing Variability in Hearing Aid Outcomes Among Older Adults

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hearing Loss
• Intervention / Treatment: Other: Hearing Aids

Detailed Description

The clinical trial portion of the project will validate clinical use of the toolset by evaluating a population of patients fit using current standard of care. Patient characteristics, such as audiological profile and cognition, will be collected. Their hearing aid settings will then be evaluated to determine if they meet toolset guidelines for signal processing based on their patient characteristics (auditory and cognition). Data regarding subjective and objective hearing aid outcomes will also be collected. It is hypothesized that hearing aid fittings that meet the standards of the proposed clinical toolset will result in better patient outcomes (objective and subjective) and fewer post-fitting visits.

• Study Type: Observational
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kendra Marks, AuD; Phone Number: 847-467-0897; Email: kendra.marks@northwestern.edu
• Study Contact Backup: Name: Pamela Souza, PhD; Phone Number: 847-491-2433; Email: p-souza@northwestern.edu

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population will be recruited from the Northwestern University Center for Audiology, Speech, Learning, and Language. They will be adults (18+) who are new hearing aid users with no recent prior hearing aid experience. Any patient at the clinic who purchases a new pair of hearing aids and meets the study criteria will be provided information about the study.

Description

Inclusion Criteria:

• sensorineural hearing loss with pure-tone thresholds 70 dB HL or better 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:

• recent (within last 12 months) hearing aid use
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
New Hearing Aid Users fit with standard-of-care; Adults (18+) with hearing loss and newly fit with hearing aids	Other: Hearing Aids; The signal processing of newly fit hearing aids will be evaluated for acceptability based on the toolset, which takes additional patient information beyond hearing threshold (like cognition) to determine the optimal hearing aid signal processing strategies.; Other Names: Hearing Aid Fitting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech intelligibility	Repeat low-context sentences	Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-fitting adjustment visits	Number of times hearing aid adjustments are made post-fitting	First 30 days of fitting
Speech and Spatial qualities questionnaire (SSQ)	Questionnaire evaluating subjective perception of hearing ability in different environments	Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 1R01DC012289-06 (U.S. NIH Grant/Contract)

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