Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
- Conditions
- Hearing Loss
- Interventions
- Device: Hearing amplification
- Registration Number
- NCT04739436
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unilateral hearing aid fitting group Hearing amplification - Bilateral hearing aid fitting group Hearing amplification -
- Primary Outcome Measures
Name Time Method Change in Hearing Aid Benefit Baseline, 3 months Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)
- Secondary Outcome Measures
Name Time Method Number of participants in each arm that chose 1 hearing aid as measured by patient preference 3 months Measured by participant's final choice of 0, 1, or 2 hearing aids
Number of participants in each arm that chose 2 hearing aids as measured by patient preference 3 months Measured by participant's final choice of 0, 1, or 2 hearing aids
Change in Hearing Aid Benefit Baseline, 3 months, 6 months Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)
Change in Hearing Aid Benefit as measured by speech in noise performance Baseline, 3 months Bamford -Kowal-Bench speech in noise (BKB SIN) test
Experience with hearing aid assignment 3 months Measured by open ended questions and discussion during a participant focus group
Number of participants in each arm that chose 0 hearing aids as measured by patient preference 3 months Measured by participant's final choice of 0, 1, or 2 hearing aids
Change in Hearing Aid Benefit as measured by Auditory Working Memory Baseline, 3 months Abbreviated Word Auditory Recognition and Recall Measure (WARRM)
Hearing aid expectations Baseline Measured by Expected Consequences of Hearing Aid Ownership (ECHO) survey completion
Change in global hearing aid outcomes 3 months, 6 months Measured by International Outcome Inventory for Hearing aids (IOI_HA) survey completion
Change in Hearing Aid Satisfaction 3 months , 6 months Measured by Satisfaction with Amplification in Daily Life (SADL) survey completion
Hours of Hearing Aid Use 3 months Measured by automated data log extracted from hearing aid
Change in Hearing Related Quality Life Baseline, 3 months, 6 months Measured by Hearing Handicap Inventory for Elderly (HHIE) survey completion
Change in complex ecological listening Baseline, 3 months, 6 months Measured by Speech Spatial Qualities (SSQ) survey completion
Preference with hearing aid assignment 3 months Measured by open ended questions and discussion during a participant focus group
Trial Locations
- Locations (2)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States