Clinical Survey of Oticon Medical Ponto BHX Implant

Oticon Medical

Status: Completed

Conditions: Deafness Unilateral; Hearing Impaired (Partially); Hearing Impairment, Conductive

Treatments: Device: BHX implant (Bone anchored hearing system)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03289845

C55

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

BHX implant

Other group

Description:

All patients implanted with BHX implant

Treatment:

Device: BHX implant (Bone anchored hearing system)