Hearing LossNCT06844071
The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
An observational study of Hearing Loss, run by Oticon Medical at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Hearing Loss
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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.
Who may be able to join
- Subjects must meet the following criteria to be eligible for participation in the investigation:
- 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:
- 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).
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- 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.
- 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.
- Subjects and parent(s) or legal guardian have the ability and willingness to comply with all investigational procedures/requirements, as determined by the Investigator.
Who cannot join
- Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
- 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.
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- 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.
- Known abnormally progressive sensorineural hearing loss.
- 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.
- 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.
- Known need for frequent MRI investigations for follow-up of other diseases.
- Current or known future use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
- Known retro cochlear pathology and auditory processing disorders that may have an impact on the outcome of the investigation.
- Any other known condition (e.g., developmental or learning delay or disability) that the investigator determines could interfere with compliance or investigation assessments.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atlanta Institute for ENT
Atlanta, Georgia, 30342
Jolie Fainberg, AuD
About this study
Official title: The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents With Mixed/Conductive Hearing Loss and Single Sided Deafness
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).
- Conditions
- Hearing Loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A. To demonstrate that the Sentio system improves hearing on the implanted ear.
Measured: 3months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start15 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844071
- Sponsor's protocol ID
- BC120
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents With Mixed/Conductive Hearing Loss and Single Sided Deafness
- ClinicalTrials.gov ID
- NCT06844071
- Acronym / sponsor ID
- BC120
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects | – | – |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (10 listed)
- Subjects must meet the following criteria to be eligible for participation in the investigation:
- 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.
Key exclusion criteria (18 listed)
- Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A. To demonstrate that the Sentio system improves hearing on the implanted ear.
Time frame: 3months post implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Oticon Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Amichetti, PhD, MSc (609-366-0424, nitc@oticonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A. To demonstrate that the Sentio system improves hearing on the implanted ear. (time frame: 3months post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.