CompletedNot Applicable

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

Australia11 participantsStarted 2019-02-19

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Abbreviated Profile of Hearing Aid Benefit (APHAB)

Timeframe: Day 0 (Visit 1) and after 6 weeks (Visit 3)

Speech, Spatial, and Qualities of Hearing Scale (SSQ)

Timeframe: Day 0 and after 6 weeks

Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)

Timeframe: Day 0 and after 6 weeks

Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)

Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3

Audiometric Thresholds in Freefield, Individual Frequencies

Timeframe: 6 weeks after study start

Adaptive Speech Recognition in Noise Ratio

Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3

Speech in Quiet

Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3

Trial details

NCT IDNCT03848910

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-23

Results submitted2019-12-16

View on ClinicalTrials.gov More Deafness; Sensoneural Single Sided trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Abbreviated Profile of Hearing Aid Benefit (APHAB)

Timeframe: Day 0 (Visit 1) and after 6 weeks (Visit 3)

Speech, Spatial, and Qualities of Hearing Scale (SSQ)

Timeframe: Day 0 and after 6 weeks

Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)

Timeframe: Day 0 and after 6 weeks

Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)

Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3

Audiometric Thresholds in Freefield, Individual Frequencies

Timeframe: 6 weeks after study start

Adaptive Speech Recognition in Noise Ratio

Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3

Speech in Quiet

Timeframe: Baseline at visit 1, 6 weeks after study start at visit 3