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Clinical evidence on the Osia® System


Clinical evidence on the Osia® System

The system uses an implantable Piezo PowerTM transducer that is fixed to the bone via an osseointegrated implant. Power to drive the.

Clinical performance, safety, and patient-reported outcomes of an ...

Extended follow-up data collected as part of this clinical study demonstrate that the Osia 2 System remains a safe and effective treatment for ...

Clinical performance of the Osia™ system, a new active ... - PubMed

Background: Bone-conduction hearing implants are standard of care devices.Aims/Objectives: Evaluation of a new active magnetic bone-conduction hearing ...

Clinical performance, audiological outcomes, and quality of life of ...

The Cochlear Osseointegrated Steady-State Implant Bone Anchored Hearing Device (Osia) is a surgically implanted titanium apparatus that utilizes a ...

Clinical Application and Resources for Cochlear™ Bone Conduction ...

Options such as the Cochlear™ Osia® System*, Baha® Start or Baha® System** are predictable and cost-effective solutions that provide excellent ...

Comparative Clinical Effectiveness and Cost-Effectiveness of ... - MDPI

The Osia System was found to be clinically superior to the Baha Attract System, across objective audiological outcomes resulting in a clinically meaningful ...

Osia® guides

Osia System Clinical Evidence.pdf. Osia System Clinical Evidence. US/Canada English (OSI101). View and download. Osia® product catalog. OSI025-Osia-System ...

Early Osia® 2 bone conduction hearing implant experience

No patient-specific audiological data were collected as part of the CMR. The purpose of the Osia® 2 System CMR was to provide Cochlear Americas with early ...

Clinical performance of the Osia™ system, a new active ...

... This matches the findings by Goldstein et al. (2020), in which Osia 2 resulted in an average additional 4PTA gain of around 10 dB to Baha ...

A comparison with Cochlear™ Baha® Attract System outcomes

The Osia 2 System demonstrated high subjective satisfaction and improved audiological outcomes compared to the Baha Attract system in patients ...

Clinical Performance, Safety, and Patient-Reported Outcomes

The required sample size was calculated based on 6-month safety data from 51 subjects with MHL, CHL, or SSD implanted with the predecessor Osia System at five ...

Long-term data of the new transcutaneous partially implantable ...

Mean Osia system use by 04/2021 was 30.9 ± 8.6 months (range 17–40 months). Unaided bone conduction thresholds were unchanged postoperatively.

November 15, 2019 Cochlear Americas Chinda Hemmavanh Senior ...

... data for the Osia 2 System and Osia System (Predicate device system) ... Clinical. Performance. Clinical performance data was gathered through a ...

Cochlear™ Osia® System - ENT Ballarat

example, clinical evidence shows that while many surgeries are successful, in 30% of cases there remains hearing loss that requires further treatment2 and.

Minimally invasive subperiosteal pocket technique for Osia 2 system

The Osia System features a slim, discreet sound processor that supports direct streaming and connectivity with various wireless devices. Since ...

Osia 2 Pediatric Expansion Study - ClinicalTrials.Veeva

The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and ...

A New Active Osseointegrated Implant System in Patients with ...

As the Osia has recently been CE certified and is new on the market, with limited patient outcome data for SSD available, the objective of this ...

Early Osia® 2 bone conduction hearing implant experience

Methods: Nationwide data collected during a controlled-market release (CMR) of the Cochlear™ Osia® 2 System as well as outcomes at single, ...

Clinical Investigation Plan: CAM5766 - ClinicalTrials.gov

The intent of the study is to gather the applicable safety and effectiveness data to expand the current indications for use of the Osia 2 System ...

Bone-Anchored Hearing Aids - Medical Clinical Policy Bulletins

Available evidence suggests that the improvements in hearing with the Attract system are similar to those of a fully-implantable bone conduction (bone-anchored) ...