Completed

SONUSOsia 3 Sound Processor for Adults with Hearing Loss

Study Aim

This study will evaluate the effectiveness and user experience of the Osia 3 Sound Processor in adults with hearing loss.

What is being tested

Cochlear™ Osia® System (Osia® 2)

+ Cochlear™ Osia® System (Osia® 3)

Device

Who is being recruted

Ear Diseases+8

+ Hearing Disorders

+ Hearing Loss, Conductive

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorCochlear

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 9, 2025

Actual date on which the first participant was enrolled.

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, including mixed hearing loss, conductive hearing loss, or single-sided deafness. The aim is to determine whether this new sound processor provides better hearing performance and sound quality compared to the earlier model, the Osia 2 Sound Processor. This research is important because it could lead to improved hearing solutions for adults with these specific hearing challenges, potentially enhancing their quality of life by providing clearer and better sound experiences. Participants in the study will take part in speech performance tests, which will measure how well they can hear and understand speech in both quiet and noisy environments. They will also complete a questionnaire to share their personal experiences and satisfaction with the sound quality of the device. These evaluations help researchers determine if the Osia 3 Sound Processor offers superior performance to the previous model, contributing valuable information for improving hearing aid technology.

Official TitleA 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

NCT07156461

Principal SponsorCochlear

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesHearing DisordersHearing Loss, ConductiveNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsHearing LossHearing Loss, Mixed Conductive-Sensorineural

Criteria

6 inclusion criteria required to participate

Willing and able to provide written informed consent.

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.

Show More Criteria

7 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Cochlear Americas, Denver Research and Technology Lab

Denver, United StatesOpen Cochlear Americas, Denver Research and Technology Lab in Google Maps

Suspended

Cochlear Macquarie, Macquarie University

Sydney, Australia

Suspended

HEARnet Clinical Studies

Melbourne, Australia

Completed3 Study Centers