RECRUITING

The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-08-15

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06844071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Nicole Amichetti, PhD, MSc

CONTACT

609-366-0424

nitc@oticonmedical.com

Study Locations (Sites)

Atlanta Institute for ENT

Atlanta, Georgia, 30342

United States

Collaborators and Investigators

Sponsor: Oticon Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-08-15

Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

Hearing Loss