Efficacy of a Coupler-based Fitting Approach for Experienced Users Receiving Replacement Hearing Aids

NCT03569228 | Terminated Results FDA Device

• 1 other identifier: C2777-R
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

Hearing loss is among the top service-connected disabilities in Veterans. Hearing aids are the primary intervention for hearing loss. Half of the hearing aids dispensed in the VA are to Veterans who are receiving replacement amplification. Many Veterans would like their replacement hearing aids mailed to them, but they are required to travel to the clinic so that the fit of the hearing aid can be verified. There are standard fitting procedures, such as those used in infants and children, that use a coupler to simulate the patient's real ear to verify the hearing aid fitting. The results of this study should determine the efficacy of a coupler-based hearing-aid fitting protocol that would not require the Veteran to attend the fitting appointment, thereby contributing to improved Veteran-Centric care.

Conditions

Hearing Loss

Keywords

hearing loss; hearing aids

Outcome Measures

Primary Outcomes (1)

• Deviation From Target (in dB)

  The primary outcome of interest is based on fitting accuracy across ears (i.e., the averaged absolute deviation from target of the average of 500, 1000, 2000, and 4000 Hz across both ears measured in decibels (dB)).

  1 month

Secondary Outcomes (5)

• Abbreviate Profile of Hearing Aid Benefit

  1 month

• Client-Oriented Scale of Improvement

  1 month

• International Outcomes Inventory for Hearing Aids

  1 month

• Satisfaction With Amplification in Daily Life

  1 month

• Client Oriented Scale of Improvement (COSI)

  1 month

Other Outcomes (1)

• Deviation From Target for Open-Fit Corrections

  Single session laboratory-based observational visit

Study Arms (7)

Study 1 (In-the-Ear) Group

EXPERIMENTAL

Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.

Device: Study 1 - ITE hearing aids

Study 1 (Behind-the-Ear) Group

EXPERIMENTAL

Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.

Device: Study 1 - BTE hearing aids

Study 2 (Open-Fit corrections)

NO INTERVENTION

Participants with hearing loss will be fitted monaurally with 12 stock non-custom, receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids using the standard in-situ approach and test box measures will be made of each fitting to develop correction factors for these styles.

Study 3 (open-fit comparison)

ACTIVE COMPARATOR

This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.

Device: Study 3 (open-fit comparison)

Study 3 (closed-fit comparison)

ACTIVE COMPARATOR

This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.

Device: Study 3 (closed-fit comparison)

Study 3 (experimental open-fit)

EXPERIMENTAL

Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.

Device: Study 3 (experimental open-fit)

Study 3 (experimental closed-fit)

EXPERIMENTAL

Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.

Device: Study 3 (experimental closed-fit)

Interventions

Study 1 - ITE hearing aids DEVICE

Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.

Study 1 (In-the-Ear) Group

Study 1 - BTE hearing aids DEVICE

Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.

Study 1 (Behind-the-Ear) Group

Study 3 (open-fit comparison) DEVICE

This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.

Study 3 (open-fit comparison)

Study 3 (closed-fit comparison) DEVICE

This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.

Study 3 (closed-fit comparison)

Study 3 (experimental open-fit) DEVICE

Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.

Study 3 (experimental open-fit)

Study 3 (experimental closed-fit) DEVICE

Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.

Study 3 (experimental closed-fit)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study 1 and 3
• experienced hearing-aid users who are obtaining replacement VA-issued hearing aids of the same style and manufacturer as their current hearing aids
• no more than a moderate sensorineural hearing loss (defined as \< 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU)
• symmetrical hearing between the ears as defined as no more than a 20 dB difference in pure-tone thresholds at two consecutive frequencies
• % word-recognition abilities in quiet as measured during the diagnostic audiologic evaluation
• An education-adjusted score of \>21 on the Montreal Cognitive Assessment
• ability to read and write in English
• Study 2 Veterans aged 18-85 years with sensorineural hearing loss

You may not qualify if:

• Study 1 and 3
• outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
• a significant change in hearing on audiogram obtained during the current study and that obtained when fitted with the current (to-be replaced) hearing aids as defined by a 15 dB decline in thresholds at three consecutive frequencies in either ear
• lack of phone or non-use of the phone
• unwilling or unable to be mailed hearing aids
• co-morbid condition that would preclude their participation
• Study 2
• co-morbid condition that would preclude their participation
• outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination due to small number of subjects analyzed. Study 2 was not a clinical trial and data used to inform correction factors for Study 3.

Results Point of Contact

• Title: Candice Quinn, Principal Investigator
• Organization: Department of Veterans Affairs

candice.quinn@va.gov

919-922-8046

Study Officials

• Candice M Quinn, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Study 1. Participants obtaining replacement in-the-ear (ITE) or behind-the ear (BTE) hearing aids will be assigned to the ITE or BTE coupler-based fitting groups. Study 2: Participants will be fitted with open-fit hearing aids using simulated audiograms. Study 3. Participants obtaining replacement open fit or receiver-in-the canal hearing aids will be randomly assigned to the standard of care fitting groups (open or closed) or the coupler-based fitting groups (open or closed).

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: October 28, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)