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
This trial does not accept healthy volunteersQualifiers
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 population
The investigation population will be comprised of the main patient groups indicated for the Sentio system: patients with either conductive/mixed hearing loss, SSD patients, or patients who for some reason cannot or will not use an AC CROS. The Sentio system is indicated for patients above the age of 12 and the investigation population will enroll adolescents between 12-17 years.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
25 Participants
are grouped into 1 trial groupGroup A: subjects
Trial outcomes
Primary outcomes
1
A. To demonstrate that the Sentio system improves hearing on the implanted ear.
Time frame
3months post implantationSponsors and contacts
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Source ClinicalTrials.gov