The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.
Study Type
OBSERVATIONAL
Enrollment
100
The Sentio system is an active transcutaneous bone conduction hearing system (single armed study)
Rate of succesful use of the device
Successful use is defined as a composite outcome consisting of completion of the surgical procedure and patient reported satisfaction after fitting and use of the device (assessed through a device specific questionnaire).
Time frame: Completion of the surgical procedure is reported at the surgery. Device specific questionnaire is typically completed within the first year of follow-up, though timing may vary depending on local practice for follow-up.
Frequency of surgical events and complications
Time frame: During surgery
Assess surgical approaches and techniques
Time frame: During surgery
Frequency of post-operative complications
Time frame: From surgery till end of follow-up (expected up to 10 years)
Timing of fitting
Days between surgery and fitting of sound processor.
Time frame: During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice)
To assess improvement in hearing
Free-field thresholds
Time frame: At fitting and throughout follow-up period (expected up to 10 years)
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