N/A
Completed N=20
Lab Evaluation of Novel Hearing Aid Coupling Method
Source: ClinicalTrials.gov NCT05377359 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Sound Quality Ratings While Streaming — 43.15; 60.025; 64.025; 49.00 Units on a rating scale
Summary
Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sound Quality Ratings While Streaming |
43.15; 60.025; 64.025; 49.00; 62.9; 68.325 | — |
| SECONDARY Situational Preference Ratings |
82.225; 23.125; 50.35; 21.95; 84.225; 29.2 | — |
Eligibility Criteria
Inclusion Criteria
- Hearing aid candidate
- Meets the fitting requirements for novel and traditional coupling options
- Healthy outer ear - no visible congenital or traumatic deformity
- Symmetrical hearing loss
- No air-bone gap greater than 10 dB at 500, 1000, 2000, and 4000 Hz
- Ability to answer questions and repeat sentences
- No history of problematic tinnitus or pain/discomfort from loud sounds
- No history of active drainage from the ears in the past 90 days
- Informed consent as documented by signature.
Exclusion Criteria
- Limited mobility (not able to attend scheduled visits)
- Inability to produce reliable hearing test results
- History of active drainage from the ear in the previous 90 days
- Abnormal appearance of the eardrum and ear canal
- Known psychological problems.
Data sourced from ClinicalTrials.gov (NCT05377359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.