hearing disability hearing impairment
Conditions
Interventions
The intervention in this study is the Sentio system, which is a Bone Anchored
Hearing Systems (BAHS).
BAHS have been available for several years and more than 200,000 implantations
have been perfor
Sponsors
Oticon Medical AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary endpoints are: Functional gain with Sentio system, i.e. the difference between pre-operative unaided and aided sound field thresholds assessed 3 months post-surgery, on the implanted ear. The functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4). Difference in speech recognition score in percent between Sentio assessed 3 months post-surgery and pre-operative unaided condition, measured in quiet on the implanted ear. MRI sub-study: Subject's experience of underging an MRI scan with regards to the implant site (e.g. pain and pressure) and overall experience (e.g. claustrophobia). Radiologist's experience of conducting the scan on patients with a Sentio Ti implant, and complications and mitigating actions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional gain (PTA4) on the implanted ear at fitting, 6-, 12- and 24-months post-surgery. Functional gain on the implanted ear for frequencies: 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz at fitting, 3-, 6-, 12- and 24-months post-surgery. Aided threshold on the implanted ear for frequencies: 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz at fitting, 3-, 6-, 12- and 24-months post-surgery. Speech recognition score in percent on the implanted ear assessed in quiet at 3-, 6-, 12- and 24-months post-surgery. Difference in speech recognition score in percent between Sentio assessed 6- and 12-months post-surgery and pre-operative unaided condition, measured in quiet on the implanted ear. Signal to noise ratio (SNR) for speech intelligibility in noise with Sentio at fitting, 3-, 6-, and 24-months post-surgery on the implanted ear Effective gain (PTA4) assessed 3 months post-surgery on the implanted ear. Effective gain for frequencies 500, 1000, 2000, 3000, 4000 Hz, assessed 3 and 6 months post-surgery on the implanted ear. Difference in aided thresholds (PTA4) between Ponto on softband preoperatively and the Sentio system assessed 3 months post-surgery, on the implanted ear. Difference in aided thresholds on individual frequencies (250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz) between Ponto on softband preoperatively and the Sentio system assessed 3 months post-surgery, on the implanted ear. Difference in speech intelligibility in noise (SNR in dB) between Ponto on softband preoperatively and the Sentio system assessed 3 months post-surgery, on the implanted ear. GBI score at 3 months post-surgery IOI-HA score at 6 months and 24 months post fitting Difference in SSQ12 score between Sentio 3 months and 12 months post-surgery and pre-operative unaided condition Difference in HUI score between baseline, 3 months and 12 months Evaluation of satisfaction, usability and comfort at 3 months post-surgery as | — |
Countries
Netherlands
Outcome results
None listed