SONUSOsia 3 Sound Processor for Adults with Hearing Loss
This study will evaluate the effectiveness and user experience of the Osia 3 Sound Processor in adults with hearing loss.
Cochlear™ Osia® System (Osia® 2)
+ Cochlear™ Osia® System (Osia® 3)
Ear Diseases+8
+ Hearing Disorders
+ Hearing Loss, Conductive
Treatment Study
Summary
Study start date: September 1, 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.29 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy 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
Cochlear Macquarie, Macquarie University
Sydney, AustraliaHEARnet Clinical Studies
Melbourne, Australia