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

Cochlear

Status: Completed

Conditions: Hearing Loss, Conductive; Bone Conduction; Hearing Loss, Mixed; Single-Sided Deafness

Treatments: Device: Cochlear™ Osia® System (Osia® 3); Device: Cochlear™ Osia® System (Osia® 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07156461

CLTD5861

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Cochlear™ Osia® 2 Sound Processor

Active Comparator group

Description:

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.

Treatment:

Device: Cochlear™ Osia® System (Osia® 2)

Device: Cochlear™ Osia® System (Osia® 3)

Cochlear™ Osia® 3 Sound Processor

Experimental group

Description:

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.

Treatment:

Device: Cochlear™ Osia® System (Osia® 2)

Device: Cochlear™ Osia® System (Osia® 3)