Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis) · Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
Bottom Line
View on ClinicalTrials.gov: NCT03509974 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Osseointegrated Steady State Implant (Device)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Type and Severity of Adverse Events in the Pediatric Population Implanted With the Osia System |
1; 1; 1; 1; 1; 1 | — |
Summary
Eligibility Criteria
Inclusion Criteria: Individuals 5 through 18 years of age will be eligible for inclusion in the investigation if all of the criteria below are met:
Conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure-tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of less than or equal to 55 dB HL.
Subject does not benefit from or will not wear a conventional hearing aid.
Note: Candidates may include individuals seeking new implantation unilaterally (in one ear) or bilaterally (both ears) as well as individuals already implanted with a bone-anchored device seeking a second-side implant.
OR
Single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure-tone average (PTA4; mean of 0.5, 1, 2, and 3 kHz) of less that equal to 20 dB HL in the good ear.
Subject does not benefit from or will not wear a conventional hearing aid
Exclusion Criteria
Uncontrolled diabetes as judged by the investigator. Subject who has received radiotherapy in the area of implantation, or such radiotherapy is planned during the study period.
Current use of ototoxic drugs. Condition that could jeopardize osseointegration and/or wound healing or condition that may have an impact on the outcome of the investigation as judged by the investigator.
Insufficient bone quality and quantity for implantation of a BI300 Implant, as determined by the surgeon.
Unable to follow investigational procedures. Participation in another clinical investigation with pharmaceutical and/or device
Data sourced from ClinicalTrials.gov (NCT03509974). 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.