RECRUITING

Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07156461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Implanted with a Cochlear Osia Implant (OSI100, OSI200, OSI300)
  2. * 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).
  3. * Aged 18 years or older, at time of consent.
  4. * Minimum experience of 1 month with the Osia 2 Sound Processor.
  5. * Fluent speaker in the language used to assess speech perception performance.
  6. * Willing and able to provide written informed consent.
  1. * Ongoing infection at or around the sound processor area.
  2. * Bilaterally implanted with a Cochlear Osia Implant.
  3. * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
  4. * Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
  5. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  6. * Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
  7. * 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).

Contacts and Locations

Study Contact

PRS Specialist
CONTACT
+61 2 9428 6555
cltd-prs-admin@cochlear.com

Principal Investigator

PRS Specialist
STUDY_DIRECTOR
Cochlear Ltd

Study Locations (Sites)

Cochlear Americas, Denver Research and Technology Lab
Denver, Colorado, 80124
United States

Collaborators and Investigators

Sponsor: Cochlear

  • PRS Specialist, STUDY_DIRECTOR, Cochlear Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-09
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Bone Conduction

Additional Relevant MeSH Terms

  • Hearing Loss, Mixed
  • Hearing Loss, Conductive
  • Single-Sided Deafness
  • Bone Conduction