The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents (NCT06844071) | Clinical Trial Compass
RecruitingNot Applicable
The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
United States25 participantsStarted 2025-08-15
Plain-language summary
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).
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
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 (signed by parent or legal guardian and child).
. Subjects aged 12 to 17 years of age (inclusive)
. Subjects with the following audiometric criteria consistent with the current and approved labeling of the device:
.1 Conductive or mixed hearing loss with a 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 with a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing (AC) thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
.3 OR subjects who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A. To demonstrate that the Sentio system improves hearing on the implanted ear.
. 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.
. Known conditions that could jeopardize wound healing and skin condition e.g. uncontrolled diabetes over time or skin or scalp condition(s) that may preclude attachment to, or interfere with usage of, the sound processor as judged by the investigator.
. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.
. For bilateral asymmetric\* candidates, subjects already treated with a bone-anchored hearing solution on the side with the best BC thresholds.
. Known chronic or non-revisable vestibular or balance disorder.