Status:
COMPLETED
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
Lead Sponsor:
Cochlear
Conditions:
Deafness; Sensoneural Single Sided
Conductive Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Pro...
Eligibility Criteria
Inclusion
- Completed clinical investigation CBAS5539, and an active user of the Osia System.
- Signed Informed consent.
- Subject with conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB HL.
- OR subject with single-sided sensorineural deafness. Air conduction thresholds with a pure tone average PTA4 of ≤ 20 dB (decibel) HL (Hearing Level) (mean of 0.5, 1, 2 and 3 kHz) in the good ear.
- \- Optimally fitted with Osia Sound processor, according to subject's experience prior to inclusion.
Exclusion
- Any ongoing soft tissue complication that could significantly affect the use of the Osia 2 Sound Processor during the 6 weeks period
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
- Unable to follow investigational procedures and instructions, e.g. inability to complete quality of life scales or audiological testing as described in the Clinical Investigation Plan (CIP).
- Participation in another clinical investigation with pharmaceutical and/or device.
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03848910
Start Date
February 19 2019
End Date
April 23 2019
Last Update
October 14 2021
Active Locations (1)
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1
HEARing CRC550 Swanston Street, Carlton
Melbourne, Victoria, Australia, 3053