Individually-guided Hearing Aid Fitting

NCT03345654 | Completed

• 1 other identifier: 1R01DC012289-06
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Speech intelligibility

  Repeat low-context sentences

  Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later

Secondary Outcomes (2)

• Post-fitting adjustment visits

  First 30 days of fitting

• Speech and Spatial qualities questionnaire (SSQ)

  Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later

Study Arms (1)

New Hearing Aid Users fit with standard-of-care

Adults (18+) with hearing loss and newly fit with hearing aids

Other: Hearing Aids

Interventions

Hearing Aids OTHER

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.

Also known as: Hearing Aid Fitting

New Hearing Aid Users fit with standard-of-care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• University of Colorado, Boulder: collaborator

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: September 8, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)