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

N/ANot Yet RecruitingNCT07130136

Cochlear20 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bone Conduction Hearing Loss, Conductive Hearing Loss, Mixed

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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)

Speech perception in noise will be assessed using the Bamford-Kowal-Bench-Speech in Noise (BKB-SIN) test, which assesses speech recognition in the presence of background noise. This test consists of lists of sentences, each containing 3-4 key words, presented at 65 dB SPL with increasingly progressive levels of background noise. One point is awarded for each correctly repeated word, and the results are used to calculate the signal-to-noise ratio (SNR) at which 50% of the key words (SNR-50) are correctly repeated.

Time frame: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3-months post-implantation (Day 90)

Secondary Outcomes

The incidence rates of Adverse Events (AEs) and Device Deficiencies (DD) (both systems)

The incidence rates of all reported AEs per device type and specific rates for DD will be assessed. A breakdown by category will be provided to indicate the proportion of patients experiencing each category (by severity, by relatedness to device or procedure, and by seriousness) of AE and DD.

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)

The frequency and types of healthcare interventions (e.g., follow-up visits, treatments, and hospitalisations) associated with the use of the device systems will be collected.

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)

Word recognition in quiet will be measured using the Arthur Boothroyd (AB) Speech Test, which assesses speech recognition in a quiet surrounding. The AB test involves monosyllables presented at 65 dB SPL, with scores recorded as the percentage of correctly repeated words at each presentation level.