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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Hearing amplification

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.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bilateral hearing aid fitting group	Device: Hearing amplification; Bilateral vs. unilateral hearing aids for hearing loss
Active Comparator: Unilateral hearing aid fitting group	Device: Hearing amplification; Bilateral vs. unilateral hearing aids for hearing loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)	The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 3 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 3 months than at baseline.	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP)	The GHABP has a categorical response scale with values of 1-5 for each item (4 pre-defined listening situations and up to 4 patient-nominated listening situations). Responses are converted to a 0-100 scale. Higher post-intervention responses are indicative of more benefit for all questions except for "In this situation, with your hearing aid, how much difficulty do you now have?" where lower scores are better.	3 months
Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test	Speech and noise collocated and the speech reception threshold (SRT) for 50% performance will be calculated (in dB speech-to-noise ratio S/N).	Baseline, 3 months
Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM)	The WARRM provides a word-recognition score and a recall score using 20 audio-recorded monosyllabic words distributed across set sizes of 2, 3, 4, 5, and 6 words. the WARRM is reported as percent correct, with higher scores indicating better performance.	Baseline, 3 months
Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey	The SADL is a 15- item questionnaire, 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item (reversed for items 2, 4, 7, 13).; A global score is used, which is the mean of scores for all items (excluding questions 11 and 14, if applicable). Higher scores indicate higher satisfaction .	3 months , 6 months
Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion	The Hearing Handicap Inventory for Elderly (HHIE) survey is a 25 -item questionnaire on a response scale of "yes (4 points), sometimes (2 points) or no (0 points)". Higher score indicates more hearing handicap. Total range of scores at a given timepoint is 0 to 100.	Baseline, 3 months, 6 months
Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey	The SSQ is a 49-item questionnaire using a response scale ranging from 0 to 10. Higher scores are better.	Baseline, 3 months, 6 months
Hours of Hearing Aid Use	Average number of hours hearing aid worn, measured by automated data log extracted from hearing aid	3 months
Hearing Aid Expectations as Measured by the Expected Consequences of Hearing Aid Ownership (ECHO) Survey	The ECHO survey is 15 questions, a 7-item response scale is used in 1-unit steps, 1 (poorest) to 7 (highest) for each item (reversed for items 2, 4, 7, 13). A global score is used, which is the mean of the scores for all items (excluding question 11, if applicable). Higher scores are better (higher expectations).	Baseline
Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey	The IOI_HA total score (ranging from 7 to 35) is calculated by summing the response across the 7 item questionnaire. Choices range from the poorest outcome (1 point) to the best outcome (5 points). Higher scores indicate better outcomes.	3 months, 6 months
Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire	Participants answered the question "How likely are you to recommend assignment to a friend or family member in need of hearing aids" on a 10-point scale (1=not at all likely, 10=very likely/full recommendation)	3 months
Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids	Measured by participant's final choice of 0, 1, or 2 hearing aids	3 months
Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)	The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 6 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 6 months than at baseline.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Sherri Smith, AuD,PhD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Deafness; Presbycusis
• Other Study ID Numbers: Pro00106077; PCORI-HL-2019C1-16059 (Other Identifier: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Open access to de-identified, coded IPD will be made available via Duke's Research Data Repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No