Pediatric Expansion Study of the Sentio System

Inclusion Criteria:

1. Signed Informed Consent Form (depending on age of child, signed by parent or legalguardian and child)

2. Subject aged 3 to 11 years

3. Subject with:

3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than orequal to 45 dB HL.

3.2 OR subject who has a profound sensorineural hearing loss in one ear and normalhearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3 OR subject indicated for an air-conductioncontralateral routing of signals (AC CROS) hearing aid, but who for some reasoncannot or will not use an AC CROS.

4. Subject and parent or legal guardian have the ability and willingness to comply withinvestigational procedures/ requirements, as determined by the investigator.

5. Subject with prior experience of amplified sound through a properly fitted hearingaid, a CROS device, or a non-surgical bone anchored solution (e.g. softband).

6. For subject with conductive or mixed hearing losses, ensure sufficient air bone gap (ABG) at the ear to be implanted.

7. Sufficient bone quality/quantity/depth or skull size for implantation of a Sentio Tiimplant as assessed according to clinical practice.

Exclusion Criteria:

1. Medical condition that contraindicates implant surgery or anesthesia as judged bythe investigator.

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 Sentiosystem.

4. Known condition that could jeopardize wound healing and skin condition, e.g.uncontrolled diabetes over time, as judged by the investigator.

5. Known skin or scalp conditions that may preclude attachment or interfere with theusage of the sound processor.

6. Evidence of conditions that would prevent good speech recognition potential asdetermined by good clinical judgment.

7. Any other known condition that the investigator determines could interfere withcompliance or investigation assessments.

8. Use of ototoxic drugs that could be harmful to the hearing, as judged by theinvestigator.

9. Subject that has received radiotherapy in the area of implantation or is planned forsuch radiotherapy or similar during the investigation period.

10. For bilateral asymmetric candidates, subject already treated with a bone-anchoredhearing solution on the side with the best bone conduction thresholds.

11. Known chronic or non-revisable vestibular or balance disorder.

12. Known abnormally progressive hearing loss.

13. Currently participating, or participated within the last 30 days, in anotherclinical investigation involving an investigational drug or device that could impactthe safety or effectiveness of the Sentio system as determined by the investigator.

14. Use of active implantable or body worn device that for medical reasons cannot beremoved or discontinued, such as CSF shunts, implantable cardiac pacemakers,defibrillators, or neurostimulators.

15. Known need for frequent MRI investigations for follow-up of other diseases.

16. Any subject that according to the Declaration of Helsinki is deemed unsuitable forinvestigation enrolment.