Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

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 Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD).

Inclusion Criteria:

• 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 Criteria:

• 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.