Hearing Loss, Mixed Conductive-SensorineuralRECONNECTNCT06338670
Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users
A study testing Cochlear Osia 3 Sound Processor and Cochlear™ Osia® 2 Sound Processor in people with Hearing Loss, Mixed Conductive-Sensorineural and Hearing Loss, Conductive, run by Cochlear at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Conductive
- What is being tested?
- Cochlear Osia 3 Sound Processor and Cochlear™ Osia® 2 Sound Processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Jul 2024to 23 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pre-market, Feasibility, Prospective, Open-label, Within Subject Investigation Evaluating the Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Recipients
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.
- Being tested
- Cochlear Osia 3 Sound Processor, Cochlear™ Osia® 2 Sound Processor
- Medical subject headings
- Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear Osia 3 Sound ProcessorDevice
Osia 3 Sound Processor including sound processor magnets and Osia 3 Aqua +
Cochlear™ Osia® 2 Sound ProcessorDevice
Osia® 2 Sound Processor and Osia 2 Aqua +
| Study group | Role | What they receive |
|---|---|---|
| Cochlear™ Osia® System | Experimental | 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. Receives: Device: Cochlear Osia 3 Sound Processor; Device: Cochlear™ Osia® 2 Sound Processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The AuSTIN corpus comprises 80 lists of 20 sentences each, recorded in female voice. The goal of the adaptive Speech-in-Noise test is to obtain the Speech Reception Threshold in noise.
Measured: 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
Aided thresholds in sound field will be measured using warble tones presented from a front speaker positioned at 1 m from the subject following the modified Hughson-Westlake procedure. Frequencies to be tested are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz.
Measured: During week 48-52
Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips
After listening to different sound clips with Osia 3 and the Osia 2 sound processors, the subjects will rate specific aspects of the sound, e.g., loudness or sound quality, on a Likert scale from 1 to 5 in steps of 1. A rating of 1 is least positive while a rating of 5 is most positive. They will also be asked to explain their sound quality experience in their own words per sound clip.
Measured: During week 48-52
Change (within subject) in the subjective rating of different aspects of sound during a walk
The investigator will hold a conversation with the participant in real-life situations while they wear the Osia 3 sound processor (sound processor only or combined with Osia 3 Aqua+) or Osia 2 sound processor. After the walk, the investigator will ask the participant to rate specific aspects of the sound they experienced on a Likert scale from 1 to 5.
Measured: During week 48-52
Percentage of participants who preferred Osia 3 over Osia 2 sound processor
Participants will be asked which device they prefer after having listened with both devices (Osia 2 and Osia 3) to different sound clips.
Measured: During week 48-52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start4 Jul 2024
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Mixed Conductive-SensorineuralStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Therese Agat, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338670
- Sponsor's protocol ID
- CLTD5839
- Acronym
- RECONNECT
- Status last verified
- Jan 2026
- First submitted
- 24 Mar 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-market, Feasibility, Prospective, Open-label, Within Subject Investigation Evaluating the Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Recipients
- ClinicalTrials.gov ID
- NCT06338670
- Acronym / sponsor ID
- RECONNECT / CLTD5839
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject
| Arm | Type | Receives |
|---|---|---|
| Cochlear™ Osia® System | Experimental | Device: Cochlear Osia 3 Sound Processor, Device: Cochlear™ Osia® 2 Sound ProcessorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear Osia 3 Sound ProcessorOsia 3 Sound Processor including sound processor magnets and Osia 3 Aqua + | Device | Cochlear™ Osia® System |
| Cochlear™ Osia® 2 Sound ProcessorOsia® 2 Sound Processor and Osia 2 Aqua + | Device | Cochlear™ Osia® System |
Primary outcome
Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL
Time frame: During week 48-52
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The AuSTIN corpus comprises 80 lists of 20 sentences each, recorded in female voice. The goal of the adaptive Speech-in-Noise test is to obtain the Speech Reception Threshold in noise.
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
Time frame: During week 48-52
Aided thresholds in sound field will be measured using warble tones presented from a front speaker positioned at 1 m from the subject following the modified Hughson-Westlake procedure. Frequencies to be tested are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz.
Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips
Time frame: During week 48-52
After listening to different sound clips with Osia 3 and the Osia 2 sound processors, the subjects will rate specific aspects of the sound, e.g., loudness or sound quality, on a Likert scale from 1 to 5 in steps of 1. A rating of 1 is least positive while a rating of 5 is most positive. They will also be asked to explain their sound quality experience in their own words per sound clip.
Change (within subject) in the subjective rating of different aspects of sound during a walk
Time frame: During week 48-52
The investigator will hold a conversation with the participant in real-life situations while they wear the Osia 3 sound processor (sound processor only or combined with Osia 3 Aqua+) or Osia 2 sound processor. After the walk, the investigator will ask the participant to rate specific aspects of the sound they experienced on a Likert scale from 1 to 5.
Percentage of participants who preferred Osia 3 over Osia 2 sound processor
Time frame: During week 48-52
Participants will be asked which device they prefer after having listened with both devices (Osia 2 and Osia 3) to different sound clips.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Agat study director
Cochlear
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Osia 3 Sound Processor and Cochlear™ Osia® 2 Sound Processor in people with Hearing Loss, Mixed Conductive-Sensorineural and Hearing Loss, Conductive, run by Cochlear at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL (time frame: During week 48-52). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.