NL-OMON51025
Recruiting
Not Applicable
A prospective, multi-center, single-arm, clinical investigation of the safety and performance of the Sentio system in users with mixed/conductive hearing losses and single sided deafness - BC101 - Safety and performance of the Sentio system
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Oticon Medical AB
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Signed Informed Consent Form
- •2\.Adult subjects (18 years or older)
- •3\.Subjects with
- •3\.1\.conductive or mixed hearing losses with pure tone average (PTA) bone
- •conduction (BC) threshold (measured at 0\.5, 1, 2 and 3 kHz) of the indicated
- •ear better than or equal to 45 dB HL.
- •3\.2\.OR subjects who have a profound sensorineural hearing loss in one ear and
- •normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air
- •conduction (AC) threshold of the hearing ear should then be better than or
- •equal to 20 dB HL (measured at 0\.5, 1, 2 and 3 kHz)
Exclusion Criteria
- •1\.Inability to undergo general or local anaesthesia
- •2\.Prior implantation with percutaneous device or middle ear implant on the side
- •to be implanted
- •3\.Known medical conditions that contraindicate undergoing surgery as judged by
- •the investigator
- •4\.Untreated ongoing middle ear infection at the time of surgery
- •5\.Known insufficient bone quality/quantity/depth or skull size (scull
- •abnormalities) for implantation of a Sentio Ti Implant
- •6\.Known or suspected contact allergy to silicone or other material used in the
- •Sentio system.
Outcomes
Primary Outcomes
Not specified
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