N/A
N=20
Osia CPT Code Study
Conductive Hearing Loss · Mixed Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT04320407 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery — 6.1 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Osia 2 System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery |
6.1 | — |
| SECONDARY Number of Device or Procedure Related Adverse Events |
15 | — |
Summary
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent.
- Proficient in English.
- Hearing loss etiology of Conductive or Mixed Conductive loss.
- Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the treatment ear.
- Aged 18 years and older.
Exclusion Criteria
- Unwilling to wear the treatment device or comply with the surgical and rehabilitation requirements of the study.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- Medical, audiological or psychological conditions, as judged by the investigator that might contraindicate participation in the clinical investigation.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
- Prior experience with a surgical bone conduction treatment option
- Insufficient bone quality to support the BI300 implant as determined by the surgeon
Data sourced from ClinicalTrials.gov (NCT04320407). 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.