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

Browse trials for

• Hearing Loss 1,091
• Deafness 609
• Presbycusis 64

Study arms

• Other
  Bilateral hearing aid fitting group

  Device: Hearing amplification

• Active comparator
  Unilateral hearing aid fitting group

  Device: Hearing amplification

Interventions

• DeviceHearing amplification

  Bilateral vs. unilateral hearing aids for hearing loss

Primary outcomes

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.

   Time frame: Baseline, 3 months

Secondary outcomes

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.

   Time frame: 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).

   Time frame: 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.

   Time frame: 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 .

   Time frame: 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.

   Time frame: 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.

   Time frame: 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

   Time frame: 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).

   Time frame: 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.

   Time frame: 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)

    Time frame: 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

    Time frame: 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.

    Time frame: Baseline, 6 months

Baseline characteristics

Study documents

• Study protocol · Jan 24, 2025
• Statistical analysis plan · Nov 13, 2024
• Informed consent form · Jan 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Open access to de-identified, coded IPD will be made available via Duke's Research Data Repository.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code