Clinical Performance of the Osia 3 Sound Processor Compared with the Osia 2 Sound Processor in Adult Osia Implant Users (RECONNECT)

Cochlear

Status: Active, not recruiting

Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Treatments: Device: Cochlear Osia 3 Sound Processor; Device: Cochlear™ Osia® 2 Sound Processor

Study type: Interventional

Funder types: Industry

Identifiers

NCT06338670

CLTD5839

Details and patient eligibility

About

This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implanted with a Cochlear Osia Implant (OSI100 or OSI200)
• Conductive or mixed hearing loss in the implanted ear. Bone conduction threshold 4-frequency pure tone average (PTA4; mean of bone conduction thresholds at 0.5, 1, 2 and 4 kHz) ≤ 55 dB HL.

OR Single-Sided Deafness in the implanted ear. Air Conduction threshold 4-frequency pure tone average (PTA4; mean of air conduction thresholds at 0.5, 1, 2 and 3 kHz) ≤ 20 dB HL in the good ear.

• 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

• Sensitivity to loud sounds.
• Ongoing infection at or around the sound processor area.
• 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Cochlear™ Osia® System

Experimental group

Description:

Participants will receive the Osia 3 and Osia® 2 sound processors. They will then complete a series of assessments designed to evaluate the clinical performance of these two sound processors. These assessments will take place across four study visits.

Treatment:

Device: Cochlear™ Osia® 2 Sound Processor

Device: Cochlear Osia 3 Sound Processor