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Osia 3 Sound Processor for Adults with Hearing Loss

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Study AimThis 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
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorCochlear
Study ContactPRS Specialist
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2025Actual 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
Study ContactPRS Specialist
Last updated: December 11, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Ear Diseases
Hearing Disorders
Hearing Loss, Conductive
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Hearing Loss
Hearing Loss, Mixed Conductive-Sensorineural
Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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.

Consists of Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, and Osia Fitting Software 2.

Consists of Osia 3 Sound Processor, Osia 3 Sound Processor Magnets, Osia 3 Charger, and Osia Fitting Software 3.
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.

Consists of Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, and Osia Fitting Software 2.

Consists of Osia 3 Sound Processor, Osia 3 Sound Processor Magnets, Osia 3 Charger, and Osia Fitting Software 3.
Study Objectives
Primary Objectives

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.
Secondary Objectives

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.

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.

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.

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.

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).

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.

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.

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.

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.

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
Recruiting
Cochlear Americas, Denver Research and Technology LabDenver, United StatesSee the location
Recruiting
Cochlear Macquarie, Macquarie UniversitySydney, Australia
Recruiting
HEARnet Clinical StudiesMelbourne, Australia
Recruiting
3 Study Centers