Clinical Survey of Oticon Medical Ponto BHX Implant

Not Applicable

Completed

• Conditions: Hearing Impaired (Partially); Hearing Impairment, Conductive; Deafness Unilateral
• Interventions: Device: BHX implant (Bone anchored hearing system)

• Registration Number: NCT03289845
• Lead Sponsor: Oticon Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-05
• Primary Completion: 2016-01-04
• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-21
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BHX implant	BHX implant (Bone anchored hearing system)	All patients implanted with BHX implant

Primary Outcome Measures

Name	Time	Method
Implant stability quotient (ISQ) at surgery	At surgery	Initial implant stability measured directly after surgery

Secondary Outcome Measures

Name	Time	Method
Surgical torque setting measured in Ncm	At surgery	The surgical torque setting used to install the implant
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
Possibility to fit the sound processor, yes/no	5-12 days post surgery	Fitting of the sound processor at 5-12 days post-surgery

Trial Locations

Locations (2)

Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,; 🇩🇰 Hellerup, Copenhagen, Denmark

Department of Oto-Rhino-Laryngology & Audiology Aalborg University Hospital; 🇩🇰 Aalborg, Denmark