A prospective, multi-center, single-arm, clinical investigation of the safety and performance of the Sentio system in users with mixed/conductive hearing losses and single sided deafness
- Conditions
- hearing disabilityhearing impairment10019243
- Registration Number
- NL-OMON51025
- Lead Sponsor
- Oticon Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
1.Signed Informed Consent Form
2.Adult subjects (18 years or older)
3.Subjects 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 or equal to 45 dB HL.
3.2.OR subjects who have a profound sensorineural hearing loss in one ear and
normal hearing 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 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.Fluent in local language
5.Subjects who have the ability and are willing to follow investigational
procedures/requirements, e.g. to complete quality of life scales.
MRI sub-study
- Enrolled in the BC101 clinical investigation.
- Signed informed consent for the MRI sub-study.
- Minimum 6 weeks post-surgery.
1.Inability to undergo general or local anaesthesia
2.Prior implantation with percutaneous device or middle ear implant on the side
to be implanted
3.Known medical conditions that contraindicate undergoing surgery as judged by
the investigator
4.Untreated ongoing middle ear infection at the time of surgery
5.Known insufficient bone quality/quantity/depth or skull size (scull
abnormalities) for implantation of a Sentio Ti Implant
6.Known or suspected contact allergy to silicone or other material used in the
Sentio system.
7.Known condition that could jeopardize wound healing and skin condition e.g.
uncontrolled diabetes over time as judged by the investigator.
8.Known skin or scalp conditions that may preclude attachment or interfere with
the usage of the SP.
9.Known retro cochlear pathology and auditory processing disorders that may
have an impact on the outcome of the investigation
10.Any other known condition that the investigator determines could interfere
with compliance or investigation assessments.
11.Use of ototoxic drugs that could be harmful to the hearing, as judged by the
investigator.
12.Subject that has received radiotherapy in the area of implantation or is
planned for such radiotherapy or similar during the investigation period.
13.For bilateral asymmetric candidates, subject already treated with a
bone-anchored hearing solution on the side with the best BC thresholds
14.Known chronic or non-revisable vestibular or balance disorder
15.Known abnormally progressive hearing loss
16.For conductive and mixed losses: evidence that hearing loss is
retro-cochlear or central origin
17.Participation in another clinical investigation with pharmaceutical and/or
device which might cause interference with investigation participation.
18.Use of active implantable or body worn device that for medical reasons
cannot be removed or discontinued, such as CSF shunts, implantable cardiac
pacemakers, defibrillators, or neurostimulators.
19.Known need for frequent MRI investigations for follow-up of other diseases.
20.Any subject that according to the Declaration of Helsinki is deemed
unsuitable for investigation enrolment.
MRI sub-studie:
- Use of other implantable or bodily worn devices that cannot be removed or are
not MRI safe under the conditions of the MRI scan done in this sub-study.
- Unsuitable for MRI examination for any reason, judged by the investigator
and/or the radiology staff.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The co-primary endpoints are:<br /><br><br /><br>Functional gain with Sentio system, i.e. the difference between pre-operative<br /><br>unaided and aided sound field thresholds assessed 3 months post-surgery, on the<br /><br>implanted ear. The functional gain is calculated as the average of frequencies<br /><br>500, 1000, 2000 and 4000 Hz (PTA4).<br /><br><br /><br>Difference in speech recognition score in percent between Sentio assessed 3<br /><br>months post-surgery and pre-operative unaided condition, measured in quiet on<br /><br>the implanted ear.<br /><br><br /><br>MRI sub-study:<br /><br>Subject's experience of underging an MRI scan with regards to the implant site<br /><br>(e.g. pain and pressure) and overall experience (e.g. claustrophobia).<br /><br>Radiologist's experience of conducting the scan on patients with a Sentio Ti<br /><br>implant, and complications and mitigating actions. </p><br>
- Secondary Outcome Measures
Name Time Method