Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients (OSIRIS)

Cochlear

Status: Begins enrollment in 2 months

Conditions: Hearing Loss, Conductive; Bone Conduction; Hearing Loss, Mixed

Treatments: Device: Cochlear™ Osia® System; Device: Cochlear™ Baha® System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07130136

CLTD5858

Details and patient eligibility

About

The goal of this interventional study is to evaluate the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss who have a pre-existing Baha implant and Abutment (BIA300) and are transitioning to the Osia System.

The main questions this study aims to answer are:

• Is the safety and performance of the Osia System confirmed by study findings?
• What are the benefits of the Osia System compared to the Baha Connect System?

Participants will:

• Undergo speech performance testing in both quiet and noisy environments
• Provide ratings for various questionnaires

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Implanted with a Cochlear Baha BI300 Implant in combination with a Cochlear Baha BA300 Abutment (Baha Connect)
• Mixed or conductive hearing loss in the ear implanted with the Baha Connect System
• Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of ≤ 55 dB HL in the ear implanted with the Baha Connect System
• Experience of at least 6 months with the Baha Connect System
• Candidate is judged by the investigator to be dissatisfied with their current Baha Connect System due to medical issues, e.g., recurrent adverse skin reactions, and is considered likely to benefit from transitioning to an Osia System
• Candidate is a fluent speaker in the language used to assess speech perception performance
• Candidate is willing and able to provide written informed consent
• Candidate has a retrospective medical record from the time of implantation with the Baha Connect System which the investigational site is authorized to review

Exclusion criteria

• Candidate with single-sided deafness (air conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB HL in the good ear)
• Candidate with an acute infection (Holgers grade 4) at the implant site at the time of screening
• Unable or unwilling to comply with the requirements of the clinical investigation as determined 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 Organizations or contractors engaged by Cochlear for the purposes of this investigation
• Pregnant women
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored 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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18 participants in 1 patient group

Cochlear™ Osia® System and Cochlear™ Baha® System

Experimental group

Description:

Participants undergoing transition from the Baha Connect System to the Osia System will complete a series of assessments and questionnaires designed to evaluate the clinical performance and user satisfaction of both systems.

Treatment:

Device: Cochlear™ Baha® System

Device: Cochlear™ Osia® System