Bone Anchored Hearing Aid Bone Implant
Conditions
Interventions
None listed
Sponsors
Oticon Medical AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: * 18 years or older * Patient indicated for an ear level bone anchored sound processor * Bone thickness at the implant site of at least 4 mm * Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria: * Inability to participate in follow-up * Psychiatric disease in the medical history * Mental disability * Presumed doubt, for any reason, that the patient will be able to show up on all follow ups * Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus. * Patients with natural skin height of >10 mm (as there will be additional skin reduction needed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numbness around implant, specifically mean Total sensibility 36 months after surgery. Sensibility of the skin directly around the implant is an important outcome measurement to establish a possible difference between surgery with or without skin thinning. Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations are standardized and conducted at standardized moments to assure comparability. The sequence of gnostic/vital stimuli are randomly applied by the investigator, to rule out any chance of habituation by the patient. Scoring will be done to three measures * Gnostic sensibility: 0%-100% (number of sensitive locations [0-6] / number of locations tested [6]) * Vital sensibility: 0%-100% (number of sensitive locations [0-6] / number of locations tested [6]) * Total sensibility: 0%-100% (number of sensitive locations [0-12] / number of locations tested [12]) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Compare the Surgical time between test and control group Length of surgery as measured from incision to placement of healing cap (in minutes). - Investigate the effect of soft tissue around the abutment on audiometric thresholds For all patients (test and control group) we will measure and calculate the individual difference between bone conduction audiometric thresholds with test band and on abutment for frequencies 250Hz, 500Hz, 750Hz, 1kHz, 1.5kHz, 2kHz, 3kHz, 4kHz, 6kHz and 8kHz. The Individual threshold difference is calculated for separate frequencies, and overall. The difference between mean Individual threshold difference for the test and control groups reflect the potential dampening effect of the tissue thickness surrounding the abutment. By using the same sound processor for the individual patients, device effects are reduced. - Investigate and compare the number of unplanned visits, unplanned surgical procedures and other treatments for the test and control group. Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient during 0-6 months, 0-12 months and 0-36 months - Investigate and compare the rate of adverse skin reactions Evaluation of local reactions at the site of implantation will be performed from visit 2 and onwards. If local reactions occur between scheduled visits, the subjects will be encouraged to contact the clinic for follow-up and treatment. For assessment of local reactions the Holgers classification will be used (Holgers et al 1998) - Investigate implant loss and implant stability Implant stability will be assessed at each visit using resonance frequency analysis (RFA). The measurement will be performed at abutment level, by attaching a single-use SmartPeg (Osstell, Gothenburg, Sweden) to the abutment and activating the SmartPeg with an Osstell Mentor (Osstell, Gothenburg, Sweden) handled RFA instrument. The RFA measurem | — |
Countries
Netherlands
Outcome results
None listed