Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

Hearing Loss Clinical Trial

Official title:

Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04739436
• Other study ID #: Pro00106077
• Secondary ID: PCORI-HL-2019C1-
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Presbycusis

Intervention

Device:
• Hearing amplification
Bilateral vs. unilateral hearing aids for hearing loss

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hearing Aid Benefit	Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)	Baseline, 3 months
Secondary	Change in Hearing Aid Benefit	Measured by Ecological Momentary Assessment (EMA) with in-situ Glasgow Hearing Aid Benefit Profile (GHABP)	3 months, 6 months
Secondary	Change in Hearing Aid Benefit as measured by speech in noise performance	Bamford -Kowal-Bench speech in noise (BKB SIN) test	Baseline, 3 months
Secondary	Change in Hearing Aid Benefit as measured by Auditory Working Memory	Abbreviated Word Auditory Recognition and Recall Measure (WARRM)	Baseline, 3 months
Secondary	Change in Hearing Aid Satisfaction	Measured by Satisfaction with Amplification in Daily Life (SADL) survey completion	3 months , 6 months
Secondary	Hours of Hearing Aid Use	Measured by automated data log extracted from hearing aid	1 month
Secondary	Hours of Hearing Aid Use	Measured by automated data log extracted from hearing aid	3 months
Secondary	Change in Hearing Related Quality Life	Measured by Hearing Handicap Inventory for Elderly (HHIE) survey completion	Baseline, 3 months, 6 months
Secondary	Change in complex ecological listening	Measured by Speech Spatial Qualities (SSQ) survey completion	Baseline, 3 months, 6 months
Secondary	Hearing aid expectations	Measured by Expected Consequences of Hearing Aid Ownership (ECHO) survey completion	Baseline
Secondary	Change in global hearing aid outcomes	Measured by International Outcome Inventory for Hearing aids (IOI_HA) survey completion	3 months, 6 months
Secondary	Experience with hearing aid assignment	Measured by a self-reported questionnaire using a 10 point scale (1 = not at all and 10 is very highly likely/full recommendation)	3 months
Secondary	Experience with hearing aid assignment	Measured by open ended questions and discussion during a participant focus group	3 months
Secondary	Number of participants in each arm that chose 0 hearing aids as measured by patient preference	Measured by participant's final choice of 0, 1, or 2 hearing aids	3 months
Secondary	Number of participants in each arm that chose 1 hearing aid as measured by patient preference	Measured by participant's final choice of 0, 1, or 2 hearing aids	3 months
Secondary	Number of participants in each arm that chose 2 hearing aids as measured by patient preference	Measured by participant's final choice of 0, 1, or 2 hearing aids	3 months
Secondary	Preference with hearing aid assignment	Measured by open ended questions and discussion during a participant focus group	3 months
Secondary	Change in Hearing Aid Benefit	Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)	Baseline, 3 months, 6 months