N/A
Completed N=22
Remote Microphone (RM) - A Comparative Study
Hearing Loss, Conductive
Source: ClinicalTrials.gov NCT04147611 ↗
Enrolled (actual)
22
Serious AEs
—
Results posted
Jul 2021
Primary outcomePrimary: Percentage of Correct Word Responses — 2.21; 0.1; 71.7; 87.9 percentage of correct word responses
Summary
The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology. In this study, two remote microphone technologies will be evaluated to determine benefit in speech understanding in noise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Correct Word Responses |
2.21; 0.1; 71.7; 87.9; 1.5; 11.2 | — |
Eligibility Criteria
Pediatric RM Technology Group:
Inclusion Criteria
- English speaking pediatric conduction device users and their guardian/s will be included for study.
- We will include pediatric patients 5 years of age to 17 years of age who have a conductive or mixed unilateral or bilateral hearing loss with a minimum of a 30 decibels (dB) air-bone gap.
Exclusion Criteria
- Participants who do not meet the described inclusion criteria.
Normal Hearing Controls:
Inclusion Criteria
- Adults greater than18 years of age.
- Hearing thresholds < 25 dB 500 - 4,000 Hz.
Exclusion Criteria
- Non-English speakers.
Data sourced from ClinicalTrials.gov (NCT04147611). 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.