Sentio system safety and performance for adolescents 12–17

The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents With Mixed/Conductive Hearing Loss and Single Sided Deafness

This project will test how safe and well the Sentio hearing system works for adolescents aged 12–17 with conductive or mixed hearing loss, single-sided deafness, or who need an AC CROS device.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Oticon Medical (Industry-sponsored)
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT06844071 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, single-arm post‑market study to systematically collect safety and performance data on the Sentio system when used as intended in adolescents aged 12–17. Eligible participants meet device labeling audiometric criteria (conductive or mixed hearing loss with BC PTA ≤45 dB HL, single‑sided deafness with the hearing ear AC PTA ≤20 dB HL, or indication for AC CROS) and must provide parent/guardian and child consent. Enrolled subjects will be followed at participating centers to record device-related adverse events and measures of device performance in real-world use. The collected data will inform the device’s adolescent safety profile and practical performance in routine clinical settings.

Who should consider this trial

Good fit: Adolescents aged 12–17 who meet the device’s audiometric labeling criteria (BC PTA ≤45 dB HL for conductive/mixed loss, SSD with the hearing ear AC PTA ≤20 dB HL, or AC CROS indication) and who have signed parent/guardian and child consent.

Not a fit: Patients outside the 12–17 age range, those with hearing thresholds outside the device labeling, or those unable to travel to the study site are unlikely to gain benefit from participation.

Why it matters

Potential benefit: If successful, this work could clarify the Sentio system’s safety and real-world hearing benefits for adolescents and help guide treatment decisions.

How similar studies have performed: Post‑market and premarket work on similar bone‑conduction and routing devices has supported safety and benefit in selected groups, but prospective data focused specifically on adolescents are limited.

Eligibility criteria

Inclusion Criteria:

* Subjects must meet the following criteria to be eligible for participation in the investigation:

  1. Signed Informed Consent Form (signed by parent or legal guardian and child).
  2. Subjects aged 12 to 17 years of age (inclusive)
  3. Subjects with the following audiometric criteria consistent with the current and approved labeling of the device:

     3.1 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.

     3.2 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).

     3.3 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.
  4. 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).
  5. For patients with conductive or mixed hearing losses sufficient (e.g., \>25 dB) air bone gap (ABG) at the ear to be implanted.
  6. Subjects and parent(s) or legal guardian have the ability and willingness to comply with all investigational procedures/requirements, as determined by the Investigator.

Exclusion Criteria:

* Subjects meeting any of the following criteria will not be permitted to participate in the investigation:

  1. Medical condition(s) that contraindicates implant surgery or anesthesia.
  2. Untreated ongoing middle ear infection at the time of surgery.
  3. Known or suspected contact allergy to silicone or other material used in the Sentio system.
  4. Insufficient bone quality/quantity/depth or skull size for implantation of a Sentio Ti implant, assessed according to clinical practice.
  5. 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.
  6. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.
  7. For bilateral asymmetric\* candidates, subjects already treated with a bone-anchored hearing solution on the side with the best BC thresholds.
  8. Known chronic or non-revisable vestibular or balance disorder.
  9. Known abnormally progressive sensorineural hearing loss.
  10. Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Sentio system as determined by the investigator.
  11. Use of active implantable or body worn devices that for medical reasons cannot be removed or discontinued, such as CSF shunts, implantable cardiac pacemakers, defibrillators, or neurostimulators.
  12. Known need for frequent MRI investigations for follow-up of other diseases.
  13. Current or known future use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
  14. Known retro cochlear pathology and auditory processing disorders that may have an impact on the outcome of the investigation.
  15. Any other known condition (e.g., developmental or learning delay or disability) that the investigator determines could interfere with compliance or investigation assessments.
  16. Any subject that according to the Declaration of Helsinki is deemed unsuitable for enrollment.

      * Defined as \>10 dB difference measured across PTA of .5, 1, 2, \& 3kHz

Where this trial is running

Atlanta, Georgia

• Atlanta Institute for ENT — Atlanta, Georgia, United States (Recruiting)

Study contacts

• Study coordinator: Nicole Amichetti, PhD, MSc

Conditions Hearing Loss