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

Cochlear

Status

Completed

Conditions

Mixed Hearing Loss

Conductive Hearing Loss

Deafness; Sensoneural Single Sided

Treatments

Device: Investigational device - Sound Processor

Study type

Interventional

Funder types

Industry

Identifiers

NCT03848910

CBAS5731

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.