Efficacy of a Coupler-based Fitting Approach for Experienced Users Receiving Replacement Hearing Aids
Hearing Loss
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring hearing loss, hearing aids
Eligibility Criteria
Inclusion Criteria:
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
- 50% 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
Exclusion Criteria:
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)
Sites / Locations
- Durham VA Medical Center, Durham, NC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
No Intervention
Active Comparator
Active Comparator
Experimental
Experimental
Study 1 (In-the-Ear) Group
Study 1 (Behind-the-Ear) Group
Study 2 (Open-Fit corrections)
Study 3 (open-fit comparison)
Study 3 (closed-fit comparison)
Study 3 (experimental open-fit)
Study 3 (experimental closed-fit)
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.
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.
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.
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.
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.
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.
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.