N/A
N=236
Otoacoustic Emission Suppression Study
Neonatal Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT04749524 ↗Enrolled (actual)
236
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Otoacoustic Suppression Measure — 1.95; 1.33; 2.48; 0.36 dB - Unitless Difference in dB SPL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Medial-Olivocochlear Reflex (MOCR) Strength Measurement (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Intelligent Hearing Systems
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Otoacoustic Suppression Measure |
1.95; 1.33; 2.48; 0.36; 1.57; 1.79 | — |
Summary
The focus of this project is on a physiologic auditory response called the Medial Olivocochlear Reflex (MOCR) that assesses peripheral neural function. While neural hearing loss is a significant auditory disorder in patients of all ages, more than 50% of newborn infants are screened with a technology that is not sensitive to abnormalities in neural function. The development of a time-efficient and sensitive test system to assess the MOCR will provide significant benefit to infants and patients of all ages with neural deficits who would otherwise go undetected.
Eligibility Criteria
Inclusion Criteria
- Normal middle-ear function
- Present TEOAEs.
Exclusion Criteria
- Atresia or other external ear abnormalities not allowing recording of OAEs
Data sourced from ClinicalTrials.gov (NCT04749524). 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.