CompletedNot Applicable

Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users

Australia12 participantsStarted 2024-07-04

Plain-language summary

This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors.

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: * Implanted with a Cochlear Osia Implant (OSI100 or OSI200) * Conductive or mixed hearing loss in the implanted ear. Bone conduction threshold 4-frequency pure tone average (PTA4; mean of bone conduction thresholds at 0.5, 1, 2 and 4 kHz) ≤ 55 dB HL. OR Single-Sided Deafness in the implanted ear. Air Conduction threshold 4-frequency pure tone average (PTA4; mean of air conduction thresholds at 0.5, 1, 2 and 3 kHz) ≤ 20 dB HL in the good ear. * Aged 18 years or older, at time of consent. * Minimum experience of 1 month with the Osia 2 Sound Processor. * Fluent speaker in the language used to assess speech perception performance. * Willing and able to provide written informed consent. * For voluntary visit Aqua+ in water only: Be comfortable with going into a swimming pool and putting head under water. Exclusion Criteria: * Sensitivity to loud sounds. * Ongoing infection at or around the sound processor area. * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. * Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. * Current participation, or part…

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

Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL

Timeframe: During week 48-52

Change (within subject) in aided thresholds in sound field measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz

Timeframe: During week 48-52

Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips

Timeframe: During week 48-52

Change (within subject) in the subjective rating of different aspects of sound during a walk

Timeframe: During week 48-52

Percentage of participants who preferred Osia 3 over Osia 2 sound processor

Timeframe: During week 48-52

Trial details

NCT IDNCT06338670

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-23

View on ClinicalTrials.gov More Hearing Loss, Mixed Conductive-Sensorineural 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

Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL

Timeframe: During week 48-52

Change (within subject) in aided thresholds in sound field measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz

Timeframe: During week 48-52

Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips

Timeframe: During week 48-52

Change (within subject) in the subjective rating of different aspects of sound during a walk

Timeframe: During week 48-52

Percentage of participants who preferred Osia 3 over Osia 2 sound processor

Timeframe: During week 48-52