Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users
NCT ID: NCT06338670
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2024-07-04
2025-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cochlear™ Osia® System
Participants will receive the Osia 3 and Osia® 2 sound processors. They will then complete a series of assessments designed to evaluate the clinical performance of these two sound processors. These assessments will take place across four study visits.
Cochlear Osia 3 Sound Processor
Osia 3 Sound Processor including sound processor magnets and Osia 3 Aqua +
Cochlear™ Osia® 2 Sound Processor
Osia® 2 Sound Processor and Osia 2 Aqua +
Interventions
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Cochlear Osia 3 Sound Processor
Osia 3 Sound Processor including sound processor magnets and Osia 3 Aqua +
Cochlear™ Osia® 2 Sound Processor
Osia® 2 Sound Processor and Osia 2 Aqua +
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
18 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Therese Agat
Role: STUDY_DIRECTOR
Cochlear
Locations
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The HEARing CRC
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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CLTD5839
Identifier Type: -
Identifier Source: org_study_id
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