The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorOticon Medical
About this trial
This study is a post-market, multicentre, prospective, single arm investigation aimed to systematically collect safety and performance data on the Sentio system, when used as intended for adolescents (12-17 years inclusive).
Eligibility criteria
Qualifiers
Signed Informed Consent Form (signed by parent or legal guardian and child).
Subjects aged 12 to 17 years of age (inclusive)
Prior experience with amplified sound through properly fitted amplification devices such as a hearing aid, a CROS device, or a non-surgical bone conduction solution (e.g., a softband or sound arc).
For patients with conductive or mixed hearing losses sufficient (e.g., >25 dB) air bone gap (ABG) at the ear to be implanted.
Disqualifiers
Medical condition(s) that contraindicates implant surgery or anesthesia.
Untreated ongoing middle ear infection at the time of surgery.
Known or suspected contact allergy to silicone or other material used in the Sentio system.
Insufficient bone quality/quantity/depth or skull size for implantation of a Sentio Ti implant, assessed according to clinical practice.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
25 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov