NL-OMON47361
Completed
N/A
Clinical performance of a new implant system for bone conduction hearing - CBAS5539
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- deafness
- Sponsor
- Cochlear Bone Anchored Solutions AB
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Adult subjects (18 years or older)
- •\* Subject with 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 \<\<\= 55 dB.
- •Subject with single\-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of \<\<\= 20 dB HL (mean of 0\.5, 1, 2 and 3 kHz) in the good ear
- •Subject who is indicated for an AC CROS but\*for some reason\*cannot or will not use an AC CROS (Air Conduction\-Contralateral Routing of Signal).
- •\* Signed informed consent
- •\* Previous experience from amplified sound though properly fitted amplication. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
Exclusion Criteria
- •\* Uncontrolled diabetes as judged by the investigator.
- •\* Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long\-term systemic use of corticosteroids) 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.
- •\* Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period.
- •\* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
- •\* Unable to follow investigational procedures, e.g. to complete quality of life scales.
- •\* Participation in another clinical investigation with pharmaceutical and/or device.
- •\* The subject is pregnant or lactating
- •\* The subject suffers from psychiatric and/or psychomatic disorder(s)
Outcomes
Primary Outcomes
Not specified
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