Hearing Loss, MixedSONUSNCT07156461
Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients
A study testing Cochlear™ Osia® System (Osia® 2) and Cochlear™ Osia® System (Osia® 3) in people with Hearing Loss, Mixed and Hearing Loss, Conductive, run by Cochlear at 3 sites in 2 countries.
Trial summary
The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed hearing loss, conductive hearing loss, or single-sided deafness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Mixed, Hearing Loss, Conductive, Single-Sided Deafness
- What is being tested?
- Cochlear™ Osia® System (Osia® 2) and Cochlear™ Osia® System (Osia® 3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Sep 2025to 24 Nov 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, OSI200, OSI300)
- Conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds up to 65 dB HL (up to 40 dB HL at 0.5 kHz, up to 55 dB HL at 1kHz and up to 65 dB HL at 2 and 4 kHz) or Single-Sided Deafness in the implanted ear. The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and, 3 kHz).
- 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.
Who cannot join
- Ongoing infection at or around the sound processor area.
- Bilaterally implanted with a Cochlear Osia Implant.
- 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
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
HEARnet Clinical Studies
Melbourne, Victoria, 3010
Cochlear Macquarie, Macquarie University
Sydney, New South Wales, 2109
United States1 site
Cochlear Americas, Denver Research and Technology Lab
Denver, Colorado, 80124
About this study
Official title: A Pivotal, Interventional, Prospective, Multi-centre Clinical Investigation of Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients With Mixed Hearing Loss, Conductive Hearing Loss or Single-Sided Deafness
The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed hearing loss, conductive hearing loss, or single-sided deafness.
The main questions this study aims to answer are:
- Do the findings confirm the clinical performance of the Osia 3 Sound Processor?
- Is the Osia 3 Sound Processor superior compared to the Osia 2 Sound Processor?
Participants will:
- Undergo speech performance testing in both quiet and noisy environments
- Provide ratings for a self-reported questionnaire
- Being tested
- Cochlear™ Osia® System (Osia® 2), Cochlear™ Osia® System (Osia® 3)
- Keywords
- Bone Conduction
- 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® System (Osia® 2)Device
Consists of Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, and Osia Fitting Software 2.
Cochlear™ Osia® System (Osia® 3)Device
Consists of Osia 3 Sound Processor, Osia 3 Sound Processor Magnets, Osia 3 Charger, and Osia Fitting Software 3.
| Study group | Role | What they receive |
|---|---|---|
| Cochlear™ Osia® 2 Sound Processor | Active comparator | Participants randomized to group 1 will first receive a study Osia 2 Sound Processor to use at home for 1-2 weeks, before returning to the clinic to complete various assessments. These participants will then switch to the Osia 3 Sound Processor and complete the same protocol. Receives: Device: Cochlear™ Osia® System (Osia® 2); Device: Cochlear™ Osia® System (Osia® 3) |
| Cochlear™ Osia® 3 Sound Processor | Experimental | Participants randomized to group 2 will first receive a Osia 3 Sound Processor to use at home for 1-2 weeks, before returning to the clinic to complete various assessments. These participants will then switch to the Osia 2 Sound Processor and complete the same protocol. Receives: Device: Cochlear™ Osia® System (Osia® 2); Device: Cochlear™ Osia® System (Osia® 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline
Speech perception in noise will be assessed using the Australian Speech Test in Noise (AuSTIN) at the Australian sites and the Bamford-Kowal-Bench Speech-In-Noise (BKB-SIN) test at the US site. The AuSTIN uses BKB-SIN like target sentences presented in noise and comprises of 80 lists of 20 sentences each. The BKB-SIN test contains 18 list pairs of sentences, each containing 3-4 key words, presented at 65 dB SPL with adaptive noise levels. Both tests aim to determine the signal-to-noise ratio (SNR) at which 50% of the key words are correctly repeated. For the unaided and aided measurements, speech performance in noise will be measured with speech and noise presented from a front speaker, positioned at 1 m from the subject.
Measured: At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
Secondary outcomes (9)
Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor measured at 65 dB SPL, 1-2 weeks after fitting compared to the unaided condition at baseline
Speech perception in quiet will be measured using the consonant-nucleus-consonant (CNC) monosyllabic words presented at 65 dB SPL from the front speaker. The CNC word test consists of 30 lists each with 50 words per list. The goal of the speech perception assessment in quiet is to obtain the percentage of correctly repeated words in a list, i.e., the word recognition score.
Measured: At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
Mean difference in the four-frequency sound field threshold average (PTA4, mean of sound field thresholds at 0.5, 1, 2, and 4 kHz) with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline
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: At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
Mean difference in speech perception in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at a fixed signal-to-noise ratio (SNR) of 0 dB SNR, 1-2 weeks after fitting
Speech perception in noise with a fixed SNR will be measured using the AzBio sentence test, which consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. The sentences will be presented at a fixed level of 65 dB SPL at a fixed SNR of 0 dB SNR using the accompanying noise stimulus. Each word in the sentence counts towards the overall score (percent correct). Speech will be presented from the front, while noise will be presented from the rear.
Measured: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in speech perception in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at a fixed signal-to-noise ratio (SNR) of +5 dB SNR, 1-2 weeks after fitting
Speech perception in noise with a fixed SNR will be measured using the AzBio sentence test, which consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. The sentences will be presented at a fixed level of 65 dB SPL at a fixed SNR of +5 dB SNR using the accompanying noise stimulus. Each word in the sentence counts towards the overall score (percent correct). Speech will be presented from the front, while noise will be presented from the rear.
Measured: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in the Speech Spatial and Qualities of Hearing Scale (SSQ-12) global score with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor, 1-2 weeks after fitting
The SSQ-12 involves a self-reported hearing function and the impact of hearing treatment in daily life across a variety of listening situations. It includes 3 subcategories: Speech Hearing, Spatial Hearing, and Qualities of Hearing, with each question rated on a Likert scale from 0-10 (minimum - maximum hearing abilities).
Measured: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at 50 dB SPL, 1-2 weeks after fitting
Speech perception in quiet will be measured using the consonant-nucleus-consonant (CNC) monosyllabic words presented at 50 dB SPL from the front speaker. The CNC word test consists of 30 lists each with 50 words per list. The goal of the speech perception assessment in quiet is to obtain the percentage of correctly repeated words in a list, i.e., the word recognition score.
Measured: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at 65 dB SPL, 1-2 weeks after fitting
Speech perception in quiet will be measured using the consonant-nucleus-consonant (CNC) monosyllabic words presented at 65 dB SPL from the front speaker. The CNC word test consists of 30 lists each with 50 words per list. The goal of the speech perception assessment in quiet is to obtain the percentage of correctly repeated words in a list, i.e., the word recognition score.
Measured: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor, 1-2 weeks after fitting
Speech perception in noise will be assessed using the Australian Speech Test in Noise (AuSTIN) at the Australian sites and the Bamford-Kowal-Bench-Speech in Noise (BKB-SIN) test at the US site. The AuSTIN uses BKB-SIN like target sentences presented in noise and comprises of 80 lists of 20 sentences each. The BKB-SIN test contains 18 list pairs of sentences, each containing 3-4 key words, presented at 65 dB SPL with adaptive noise levels. Both tests aim to determine the signal-to-noise ratio (SNR) at which 50% of the key words are correctly repeated. For the unaided and aided measurements, speech performance in noise will be measured with speech and noise presented from a front speaker, positioned at 1 m from the subject.
Measured: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in the four-frequency sound field threshold average (PTA4, mean of sound field thresholds at 0.5, 1, 2, and 4 kHz) with the Osia 3 Sound Processor compared to the Osia 2 Sound Processor, 1-2 weeks after fitting
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: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start9 Sep 2025
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, MixedStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- The investigation uses a repeated-measures, cross-over design where study recipients will be randomized into one of two groups (1:1 ratio)
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- PRS Specialist, Study director, Cochlear Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156461
- Sponsor's protocol ID
- CLTD5861
- Acronym
- SONUS
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Interventional, Prospective, Multi-centre Clinical Investigation of Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients With Mixed Hearing Loss, Conductive Hearing Loss or Single-Sided Deafness
- ClinicalTrials.gov ID
- NCT07156461
- Acronym / sponsor ID
- SONUS / CLTD5861
- Keywords
- Bone Conduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 5 Sep 2025 (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.
The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed hearing loss, conductive hearing loss, or single-sided deafness.
The main questions this study aims to answer are:
- Do the findings confirm the clinical performance of the Osia 3 Sound Processor?
- Is the Osia 3 Sound Processor superior compared to the Osia 2 Sound Processor?
Participants will:
- Undergo speech performance testing in both quiet and noisy environments
- Provide ratings for a self-reported questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigation uses a repeated-measures, cross-over design where study recipients will be randomized into one of two groups (1:1 ratio)
| Arm | Type | Receives |
|---|---|---|
| Cochlear™ Osia® 2 Sound Processor | Active comparator | Device: Cochlear™ Osia® System (Osia® 2), Device: Cochlear™ Osia® System (Osia® 3)Participants randomized to group 1 will first receive a study Osia 2 Sound Processor to use at home for 1-2 weeks, before returning to the clinic to complete various assessments. These participants will then switch to the Osia 3 Sound Processor and complete the same protocol. |
| Cochlear™ Osia® 3 Sound Processor | Experimental | Device: Cochlear™ Osia® System (Osia® 2), Device: Cochlear™ Osia® System (Osia® 3)Participants randomized to group 2 will first receive a Osia 3 Sound Processor to use at home for 1-2 weeks, before returning to the clinic to complete various assessments. These participants will then switch to the Osia 2 Sound Processor and complete the same protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Implanted with a Cochlear Osia Implant (OSI100, OSI200, OSI300)
- Conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds up to 65 dB HL (up to 40 dB HL at 0.5 kHz, up to 55 dB HL at 1kHz and up to 65 dB HL at 2 and 4 kHz) or Single-Sided Deafness in the implanted ear. The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and, 3 kHz).
- 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.
Key exclusion criteria (7 listed)
- Ongoing infection at or around the sound processor area.
- Bilaterally implanted with a Cochlear Osia Implant.
- 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® System (Osia® 2)Consists of Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, and Osia Fitting Software 2. | Device | Cochlear™ Osia® 2 Sound Processor, Cochlear™ Osia® 3 Sound Processor |
| Cochlear™ Osia® System (Osia® 3)Consists of Osia 3 Sound Processor, Osia 3 Sound Processor Magnets, Osia 3 Charger, and Osia Fitting Software 3. | Device | Cochlear™ Osia® 2 Sound Processor, Cochlear™ Osia® 3 Sound Processor |
Primary outcome
Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline
Time frame: At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
Speech perception in noise will be assessed using the Australian Speech Test in Noise (AuSTIN) at the Australian sites and the Bamford-Kowal-Bench Speech-In-Noise (BKB-SIN) test at the US site. The AuSTIN uses BKB-SIN like target sentences presented in noise and comprises of 80 lists of 20 sentences each. The BKB-SIN test contains 18 list pairs of sentences, each containing 3-4 key words, presented at 65 dB SPL with adaptive noise levels. Both tests aim to determine the signal-to-noise ratio (SNR) at which 50% of the key words are correctly repeated. For the unaided and aided measurements, speech performance in noise will be measured with speech and noise presented from a front speaker, positioned at 1 m from the subject.
9 secondary outcomes
Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor measured at 65 dB SPL, 1-2 weeks after fitting compared to the unaided condition at baseline
Time frame: At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
Mean difference in the four-frequency sound field threshold average (PTA4, mean of sound field thresholds at 0.5, 1, 2, and 4 kHz) with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline
Time frame: At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
Mean difference in speech perception in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at a fixed signal-to-noise ratio (SNR) of 0 dB SNR, 1-2 weeks after fitting
Time frame: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in speech perception in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at a fixed signal-to-noise ratio (SNR) of +5 dB SNR, 1-2 weeks after fitting
Time frame: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in the Speech Spatial and Qualities of Hearing Scale (SSQ-12) global score with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor, 1-2 weeks after fitting
Time frame: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at 50 dB SPL, 1-2 weeks after fitting
Time frame: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at 65 dB SPL, 1-2 weeks after fitting
Time frame: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor, 1-2 weeks after fitting
Time frame: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
Mean difference in the four-frequency sound field threshold average (PTA4, mean of sound field thresholds at 0.5, 1, 2, and 4 kHz) with the Osia 3 Sound Processor compared to the Osia 2 Sound Processor, 1-2 weeks after fitting
Time frame: At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
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 8 Jan 2026.
- Individual participant dataSharing planned: No
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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.
PRS Specialist study director
Cochlear Ltd
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear™ Osia® System (Osia® 2) and Cochlear™ Osia® System (Osia® 3) in people with Hearing Loss, Mixed and Hearing Loss, Conductive, run by Cochlear at 3 sites in 2 countries.
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 6 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 8 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 3 sites in Australia, United States. 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?
Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline (time frame: At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)). 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 8 Jan 2026.