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

Official title

Post-Market Clinical Follow-Up of the Osia System and Evaluation of Benefits of Transitioning From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients With Mixed or Conductive Hearing Loss

Overview

The goal of this interventional study is to confirm 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

Interventions

• Device Cochlear™ Osia® System
  The Osia System consists of the OSI300 Implant, Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, Osia 2 Sound Processor Magnet Tool, Osia Fitting Software 2 (OFS 2), and Osia Smart App.
• Device Cochlear™ Baha® System
  The Baha Connect System consists of the BIA300 (BI300 Implant and BA300 Abutment), Baha 7 Sound Processor, and Baha Fitting Software 7 (BFS 7).

Primary outcome measures

• Change (within-subject) in speech reception threshold in noise measured at 65 dB SPL (pre-operative unaided and post-operative aided with the Osia System) [Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3-months post-implantation (Day 90)]

Secondary outcome measures (9)

• The incidence rates of Adverse Events (AEs) and Device Deficiencies (DD) (both systems) [Time frame: From screening through to the end of study at 6 months (Day 180), including any additional visits (Ad Hoc)]
• The frequency and types of healthcare interventions related (both systems) [Time frame: At Baseline Visit 1 (2-3 weeks prior to Baseline Visit 2) to study end (Day 180)]
• Change (within-subject) in word recognition score in quiet measured at 65 dB SPL (pre-operative unaided and post-operative aided with the Osia System) [Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)]
• Total score and attribute scores from the Health Utilities Index (HUI)-2/3 questionnaire (Osia System) [Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)]
• Global score and subscale scores from the Speech Spatial Qualities of Hearing Scale (SSQ-49) questionnaire (Osia System) [Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)]
• Change (within-subject) in global Satisfaction with Amplification in Daily Life (SADL) score and subscale scores (both systems) [Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)]
• Change (within-subject) in word recognition score in quiet measured at 65 dB SPL (both systems) [Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)]
• Change (within-subject) in word recognition score in quiet measured at 50 dB SPL (both systems) [Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)]
• Change (within-subject) in word recognition score in quiet measured at 80 dB SPL (both systems) [Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)]

Eligibility criteria

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
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 3 centers

• Royal National Ear, Nose and Throat and Eastman Dental Hospitals — London
• Nottingham Auditory Implant Programme — Nottingham
• Sheffield Teaching Hospitals — Sheffield

Identifiers

NCT: NCT07130136 · CLTD5858

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗