Clinical trial NCT04739436: Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
Official title: Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-02-04
Enrollment: 278
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the benefit of bilateral hearing aid use compared to a unilateral hearing aid. Patients with mild to moderate bilateral hearing loss who are considering the purchase of a commercially available hearing aid will be considered for participation. Eligible participants will be randomized to one of the following treatment arms: (1) a bilateral hearing aid fitting group, and (2) a unilateral hearing aid fitting group.

Detailed description: Primary objectives:

1. To compare the hearing-aid benefit of unilateral versus bilateral fittings of commercially-available hearing aids that incorporate a dome coupling (open or closed dome as required by degree of hearing loss, or custom coupling if clinically indicated), which represents the most popular style used for mild to moderate hearing loss.
2. To compare other multi-dimensional outcomes including hearing-related quality of life, hearing aid satisfaction in patient-nominated goals, ecological hearing aid outcomes, and hearing aid use.

Secondary objectives:

1. To compare performance outcomes for unilateral versus bilateral hearing aid fittings
2. To explore the differences in long-term patient reported outcomes for their final hearing aid configuration choice
3. To explore patient experiences in each group (unilateral vs bilateral), and patient preference in regards to their choice of final hearing aid configuration.

This study is being conducted at Duke and Vanderbilt Medical Centers, with Duke functioning as the main coordinating center. Study participants will pay out of pocket for the hearing aid(s), but will be able to extend the hearing aid fitting trial period from 60 days (standard of care) to 180 days (6 months). Participants will be given the opportunity to change their hearing aid configuration and/or return their hearing aid(s) for a refund after 3 months, and again at the end of the 6 month study period.

Eligibility criteria: Inclusion Criteria:

* 50+ years of age
* Ability to read and understand English
* Mild to moderate sensorineural hearing loss (defined by a pure-tone average at 500, 1000, and 2000 Hz of \<55 dB HL in each ear, and the 3000 Hz and 4000 Hz threshold \<80 in each ear), based on a hearing test obtained within the last 6 months by a licensed audiologist.
* Symmetrical hearing loss defined by \<20 dB difference between the pure-tone average of 500, 1000, and 2000 Hz between ears)
* Interested in purchasing hearing aids, but is open minded about trying one or two hearing aids
* No prior hearing aid use longer than 3 months (as documented via self-report)
* Adequate literacy to complete questionnaires
* Willing to purchase study-specific hearing aid(s)
* Access to a smart phone and the internet

Exclusion Criteria:

* Concerns for middle ear pathology (e.g., air bone gap of \>15 dB at 2 consecutive octave frequencies in either ear)
* Concerns for retrocochlear pathology by audiologist (e.g unilateral tinnitus or ear fullness, referral to ENT/Auditory Brainstem Response testing to r/o acoustic neuroma)
* Severe tinnitus as the reason for seeking amplification
* Co-morbid condition that would interfere with study (e.g., dementia, blindness, neurologic pathology)
* History of fluctuating hearing loss

Primary outcomes:
measure: Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP)
timeFrame: 3 months
measure: Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test
timeFrame: Baseline, 3 months
measure: Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM)
timeFrame: Baseline, 3 months
measure: Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey
timeFrame: 3 months , 6 months
measure: Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion
timeFrame: Baseline, 3 months, 6 months
measure: Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey
timeFrame: Baseline, 3 months, 6 months
measure: Hours of Hearing Aid Use
timeFrame: 3 months
measure: Hearing Aid Expectations as Measured by the Expected Consequences of Hearing Aid Ownership (ECHO) Survey
timeFrame: Baseline
measure: Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey
timeFrame: 3 months, 6 months
measure: Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire
timeFrame: 3 months
measure: Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids
timeFrame: 3 months
measure: Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Duke Health
name: Sherri Smith, AuD,PhD
role: PRINCIPAL_INVESTIGATOR
References: