Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
A legfontosabb adatok
- Ki végzi
- Cochlear
- Hol
- Egyesült Királyság3 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 20 fő, tervezett
- Kezdés
- 2026. júl. 24.
- Várható befejezés
- 2028. dec.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Cochlear™ Osia® System
- Cochlear™ Baha® System
- A regiszteradat frissítve
- 2026. szeptember 2.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with mixed or conductive hearing loss who already use a Baha Connect implant and are moving to the Osia System.
- Életkor
- 18 years or older
- Nem
- All sexes
- A betegség stádiuma
- Mixed or conductive hearing loss in the ear with the Baha Connect System. Bone conduction hearing level (PTA4) of ≤ 55 dB HL in that ear.
- Korábbi kezelés
- Must have a Cochlear Baha BI300 Implant with a Baha BA300 Abutment (Baha Connect), used for at least 6 months. The study doctor must judge the person unhappy with it for medical reasons, such as repeated skin reactions.
A részvétel fő kizáró okai
- Hearing loss in one ear only, with the other ear hearing at ≤ 20 dB HL
- Acute infection (Holgers grade 4) at the implant site at screening
- Taking part in another study of a test drug or device in the past 30 days
- Study staff, their close family, or Cochlear employees and contractors
- Not able or willing to follow the study requirements
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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)
- Candidate with an acute infection (Holgers grade 4) at the implant site at the time of screening
- 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)
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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
A vizsgálat csoportja
- Cochlear™ Osia® System and Cochlear™ Baha® SystemA vizsgált kezelés
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.
Kezelés: Cochlear™ Osia® System és Cochlear™ Baha® System
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2026. szeptember 2.