deafness Hearing loss
Conditions
Interventions
Impantation of the ATB System
Bone conduction
Cochlear
Implant
Performance
Sponsors
Cochlear Bone Anchored Solutions AB
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Adult subjects (18 years or older) * Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of
Exclusion criteria
Exclusion criteria: * Uncontrolled diabetes as judged by the investigator. * Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator. * Insufficient bone quality and quantity for implantation of a BI300 Implant. * Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period. * Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator. * Unable to follow investigational procedures, e.g. to complete quality of life scales. * Participation in another clinical investigation with pharmaceutical and/or device. * The subject is pregnant or lactating * The subject suffers from psychiatric and/or psychomatic disorder(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: 1) To compare hearing performance with the Investigational device and the unaided hearing situation Primary outcome measure: 1) Thresholds audiometry, free-field [PTA4, Mean of 0.5, 1, 2 and 4 kHz]. Investigational device (at 3 months) vs. Unaided. 2) Adaptive speech in noise [speech-to-noise ratio, 50% speech understanding]. Investigational Device (at 3 months) vs.Unaided (preoperative). Safety objectives: Primary safety analysis at 6 months. 1) Implant site evaluations 2) Adverse Events and concomitant medication/treatment 3) Device deficiency 4) Audiogram Safety outcome measures: 1) Numbness 2) Information will be collected from visit 2 and onwards. 3) Information will be collected from Visit 2 and onwards. 4) Bone conduction thresholds preoperative and postoperative (3,6 and 12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: 1) To compare hearing performance with the Investigational device and the unaided hearing situation 2) To compare the self-reported assessments of hearing outcome with the Investigational device and in a preoperative hearing situation 3) To collect surgical information 4) To collect information about the magnet choice and daily use of sound processor 5) To measure hearing performance preoperatively with a Baha BP110 Power Sound Processor on a Baha Softband Secondary outcome measures: 1a) Thresholds audiometry, free-field [PTA4, Mean of 0.5, 1, 2 and 4 kHz]. Investigational device (4w, 6 and 12 months) vs. Unaided. 1b) Thresholds audiometry, free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]. Investigational device (4w, 3, 6 and 12 months)vs. Unaided. 1c) Adaptive speech in noise [speech-to-noise ratio, 50% speech understanding]. Investigational Device (4w, 6 and 12 months) vs. Unaided (preoperative). 1d) Speech in quiet [% correctly perceived words a 50dB, 65dB and 80dB SPL]. Investigational Device (4w, 3, 6, and 12 months) vs. Unaided (preoperative). 1e) Feedback measurements. Investigational Device (Visit 4 and onwards). 2a) Abbreviated Profile of Hearing Aid Benefit (APHAB). Investigational Device at 3 and 12 months vs. preoperative hearing situation. 2b)Health Utilities Index (HUI23S1EN.15Q). Investigational device vs. preoperative hearing situation 2c)Speech, Spatial and Qualities of Hearing Scale (SSQ). Investigational device vs. Unaided. 3 a) Soft tissue thickness 3b) Soft tissue reduction performed 3c) Type of anaesthesia 3d) Surgery time 3e) Bone polishing/removal at the actuator site 3f) BI300 Implant length 3g) Location of BI300 Implant 3h) Surgical incision type/location 4a) Daily usage time 4b) Comfort 4c) Softpad use 4d) Choice of magnet strength 5a) Thresholds audiometry, free-field [PTA4, Mean of 0.5, 1, 2 and 4 kHz]. 5b) Thresholds audiometry, free-field [0.25, 0.5, | — |
Countries
The Netherlands
Outcome results
None listed