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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Cochlear Americas, Denver Research and Technology Lab
RECRUITING
Denver
Other Locations
Australia
HEARnet Clinical Studies
RECRUITING
Melbourne
Cochlear Macquarie, Macquarie University
RECRUITING
Sydney
Contact Information
Primary
PRS Specialist
cltd-prs-admin@cochlear.com
+61 2 9428 6555
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2025-12
Participants
Target number of participants: 29
Treatments
Active_comparator: Cochlear™ Osia® 2 Sound Processor
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.
Experimental: Cochlear™ Osia® 3 Sound Processor
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.
Related Therapeutic Areas
Sponsors
Leads: Cochlear
Collaborators: Avania

This content was sourced from clinicaltrials.gov