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Hearing LossNCT04739436

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

A study testing Hearing amplification in people with Hearing Loss, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Hearing Loss
What is being tested?
Hearing amplification
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
278 participants
Where
2 sitesUnited States
Study dates
26 Apr 2021to 20 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • Adequate literacy to complete questionnaires
  • Willing to purchase study-specific hearing aid(s)
  • Access to a smart phone and the internet

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

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.

Read the 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.

Conditions
Hearing Loss
Being tested
Hearing amplification
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hearing amplificationDevice

    Bilateral vs. unilateral hearing aids for hearing loss

Study groups in NCT04739436
Study groupRoleWhat they receive
Bilateral hearing aid fitting groupOtherNot described
Receives: Device: Hearing amplification
Unilateral hearing aid fitting groupActive comparatorNot described
Receives: Device: Hearing amplification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months

Secondary outcomes (12)

  1. 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.

    Measured: 3 months

  2. 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).

    Measured: Baseline, 3 months

  3. 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.

    Measured: Baseline, 3 months

  4. 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 .

    Measured: 3 months , 6 months

  5. 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.

    Measured: Baseline, 3 months, 6 months

  6. 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.

    Measured: Baseline, 3 months, 6 months

  7. Hours of Hearing Aid Use

    Average number of hours hearing aid worn, measured by automated data log extracted from hearing aid

    Measured: 3 months

  8. 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).

    Measured: Baseline

  9. 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.

    Measured: 3 months, 6 months

  10. 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)

    Measured: 3 months

  11. 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

    Measured: 3 months

  12. 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.

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start26 Apr 2021
  3. Primary completion12 Jul 2024
  4. Study completion20 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739436
Sponsor's protocol ID
Pro00106077
Other IDs
PCORI-HL-2019C1-16059
Status last verified
Mar 2025
First submitted
26 Jan 2021
Last updated
10 Apr 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Open access to de-identified, coded IPD will be made available via Duke's Research Data Repository.

Publications

  • Smith SL, Ricketts TA, Kilpatrick KW, North R, Bettger JP, Coles T, Eberts S, Peskoe SB, Francis HW, Toth H, Dillon W, Thompson L, Branscome K, Walker A, Rockhold FW. Unilateral and Bilateral Hearing Aids for Age-Related Hearing Loss: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Aug 27:e262401. doi: 10.1001/jamaoto.2026.2401. Online ahead of print.

    PubMed 42658545

Questions about this trial

What is this clinical trial studying?

A study testing Hearing amplification in people with Hearing Loss, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739436, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

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