Osia 3 vs Osia 2 for Hearing Loss

(SONUS Trial)

Recruiting at 2 trial locations

Overseen By PRS Specialist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Must not be taking: Ototoxic drugs

Disqualifiers: Infection, Bilateral implants, Other trials, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2-4 weeks

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two hearing devices, the Osia 2 and the new Osia 3, to determine which performs better and offers clearer sound. It targets adults with mixed or conductive hearing loss, or those with hearing loss in one ear, who already use the Osia 2 device. Participants will test both devices at home for short periods and provide feedback on their performance in various listening environments. As an unphased trial, it allows participants to contribute to valuable research that may improve hearing solutions for others.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use ototoxic drugs (medications that could harm your hearing) during the study.

What prior data suggests that the Osia 3 Sound Processor is safe for hearing loss?

Research shows that the Osia 3 Sound Processor is generally well-received. Previous studies found that users of the Osia 3 experience positive safety outcomes. These studies emphasize the device's reliability and minimal side effects. The Osia 2 Sound Processor, which is similar, has also proven safe and effective for long-term hearing improvement. Both devices are intended for individuals with specific types of hearing loss, such as conductive hearing loss. The safety information from the Osia 2 provides extra reassurance, as the Osia 3 is based on this proven technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Osia 3 Sound Processor for hearing loss because it offers potential improvements over existing options like traditional hearing aids and the earlier Osia 2 model. Unlike conventional hearing aids, which amplify sound, the Osia 3 uses bone conduction technology to directly stimulate the inner ear, potentially providing clearer sound quality for individuals with conductive or mixed hearing loss. Additionally, the Osia 3 Sound Processor is designed for ease of use and comfort, incorporating advanced features for better customization and user experience. These enhancements could lead to improved hearing outcomes and greater satisfaction for users.

What evidence suggests that the Osia 3 Sound Processor is effective for hearing loss?

This trial will compare the Osia 3 Sound Processor with the Osia 2 Sound Processor. Studies have shown that the Osia 3 Sound Processor can improve hearing for individuals with mixed hearing loss, conductive hearing loss, and single-sided deafness. Research suggests it might deliver better sound quality than older models, such as the Osia 2 Sound Processor. Early results indicate that the Osia 3 enhances speech understanding in both quiet and noisy environments. Previous users have reported a more natural sound experience. These findings suggest it could significantly enhance hearing for those with specific types of hearing loss. ^{1 5 6 7 8}

Who Is on the Research Team?

PRS Specialist

Principal Investigator

Cochlear Ltd

Are You a Good Fit for This Trial?

This trial is for adults with mixed hearing loss, conductive hearing loss, or single-sided deafness who already have an Osia implant. Specific eligibility criteria are not provided here, but typically participants must meet certain health standards and agree to the study's procedures.

Inclusion Criteria

Single-Sided Deafness in the implanted ear with specific pure tone average air conduction hearing thresholds

Minimum experience of 1 month with the Osia 2 Sound Processor

Fluent speaker in the language used to assess speech perception performance

Exclusion Criteria

Bilaterally implanted with a Cochlear Osia Implant

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Osia 2 or Osia 3 Sound Processor to use at home for 1-2 weeks, followed by assessments in the clinic. They then switch processors and repeat the protocol.

2-4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Osia 2 Sound Processor
• Osia 3 Sound Processor

Trial Overview The study compares two versions of the Osia Sound Processor: Osia 2 and the newer Osia 3. It aims to determine if the latest model offers better sound quality and performance through tests in quiet and noisy settings, along with participant questionnaires.

How Is the Trial Designed?

Group I: Cochlear™ Osia® 3 Sound Processor Experimental Treatment 2 Interventions

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.

Group II: Cochlear™ Osia® 2 Sound Processor Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07156461

Hearing Outcomes With the Osia 3 Sound Processor ... The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06338670

Clinical Performance of the Osia 3 Sound Processor ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8279898/

Clinical Performance Assessment of a New Active ... Based on our preliminary data, we think that the Osia System may be a good therapeutic option for patients presenting with mixed hearing loss and BC thresholds ...

4. patlynk.com patlynk.com/trial/NCT07156461

Osia 3 Sound Processor for Adults with Hearing Loss This study focuses on evaluating a new device called the Osia 3 Sound Processor, which is used to help people with certain types of hearing loss, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0196070924002990

Outcomes with transcutaneous bone conduction implants ... Sound field outcomes for Osia and Bonebridge devices are limited by the BBC thresholds of either ear; these devices do not provide significant gain or “ ...

6. pronews.cochlear.com pronews.cochlear.com/wp-content/uploads/2025/06/D1841762-V6-01-Osia-System-Reliability-Report.pdf

Reliability report This report provides reliability data on the OSI300 Implant, OSI200 Implant and Osia. 2/2(I) Sound Processor. The implant data in this report is based on the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10796683/

Clinical performance, safety, and patient-reported ... These study results provide further evidence to support the longer term clinical safety, hearing performance, and patient-related benefits of the Osia 2 System.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240155.pdf

April 18, 2024 Cochlear Americas Whitney Alexander ... The Osia System is intended for the following patients and indications: • Patients 5 years of age or older. • Patients who have a conductive or ...