To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The external Sound Processor, Osia 2 Active Osseointegrated Implant System for Bone Conduction, captures and digitizes the sound which is transferred to the internal implant where it is converted to an electrical signal.
Arizona Ear Center
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
University of Michigan
Ann Arbor, Michigan, United States
Center for Hearing and Balance
Chesterfield, Missouri, United States
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery
Assessed with the Quick SIN test preoperative and at 3 months post-surgery. The Quick SIN test has a score range from +25.5 dB (decibel) SNR (signal-to-noise ratio) to -5 dB SNR. The participants are tested on 4 tests lists; each consists of 6 sentences (with 5 key words per sentence) that are presented at signal-to-noise ratios (SNR) which are decreased manually in 5-dB steps from 25 to 0. The key words in sentences are scored and counted as correct from an easy to difficult or unfavorable SNR. The best possible score on this test would be that of -5 dB SNR where all of the key words are repeated back correctly as a function of the SNR. The mean unaided preoperative score is substracted from the aided score at 3 months. A lower score indicates a better performance.
Time frame: Preoperative, 3 months post-surgery
Number of Device or Procedure Related Adverse Events
A device or procedure related adverse event (AE) is an AE for which a causal relationship between the use of the medical device and the AE cannot be ruled out. All related AEs are reported.
Time frame: 6 months post-surgery
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