Individually-guided Hearing Aid Fitting

Hearing Loss Clinical Trial

Official title:

Characterizing Variability in Hearing Aid Outcomes Among Older Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03345654
• Other study ID #: 1R01DC012289-06
• Status: Enrolling by invitation
• Start date: September 22, 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech intelligibility	Repeat low-context sentences	Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later
Secondary	Post-fitting adjustment visits	Number of times hearing aid adjustments are made post-fitting	First 30 days of fitting
Secondary	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