Clinical Investigation Study of Safety and Performance of the Sentio System. (NCT05166265) | Clinical Trial Compass
UnknownNot Applicable
Clinical Investigation Study of Safety and Performance of the Sentio System.
Germany, Netherlands, United Kingdom51 participantsStarted 2022-01-19
Plain-language summary
Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed Informed Consent Form
✓. Adult subjects (18 years or older)
✓. Subjects with 3.1. conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL.
✓.2. OR subjects who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3. OR subjects who are indicated for an air-conduction contralateral routing of signals (ACCROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
✓. Fluent in local language
✓. Subjects who have the ability and are willing to follow investigational procedures/requirements, e.g. to complete quality of life scales.
Exclusion criteria
✕. Inability to undergo general or local anesthesia
✕. Prior implantation with percutaneous device or middle ear implant on the side to be implanted
✕. Known medical conditions that contraindicate undergoing surgery as judged by the investigator
✕. Untreated ongoing middle ear infection at the time of surgery
✕. Known insufficient bone quality/quantity/depth or skull size (scull abnormalities) for implantation of a Sentio Ti Implant
What they're measuring
1
Demonstrate that the Sentio system improves hearing on the implanted ear.
Timeframe: 3 months post-surgery
2
Demonstrate that the Sentio system provides patients with improved speech recognition on the implanted ear.