Deafness Unilateral, Hearing Impaired (Partially), Hearing Impairment, Conductive
Conditions
Brief summary
Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient.
Interventions
DEVICEBHX implant (Bone anchored hearing system)
Bone anchored hearing system for hearing rehabilitation
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients eligible for treatment with a bone anchored hearing aid * 18 years or older
Exclusion criteria
* Inability to participate in follow-up * Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability quotient (ISQ) at surgery | At surgery | Initial implant stability measured directly after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical torque setting measured in Ncm | At surgery | The surgical torque setting used to install the implant |
| Possibility to fit the sound processor, yes/no | 5-12 days post surgery | Fitting of the sound processor at 5-12 days post-surgery |
| Implant stability quotient (ISQ) after 12 months of follow up | 12 months post surgery | Long term stability development |
| Implant survivability measured as percentage successful implants after 12 months | 12 months post surgery | Implant survivability |
Countries
Denmark
Outcome results
None listed