Clinical Survey of Oticon Medical Ponto BHX Implant

Deafness Unilateral Clinical Trial

Official title:

Clinical Survey of Oticon Medical Ponto BHX Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289845
• Other study ID #: C55
• Status: Completed
• Phase: N/A
• First received: August 31, 2017
• Last updated: February 20, 2018
• Start date: November 5, 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2017
• Est. primary completion date: January 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Deafness Unilateral
• Hearing Impaired (Partially)
• Hearing Impairment, Conductive
• Hearing Loss
• Hearing Loss, Conductive

Intervention

Device:
• BHX implant (Bone anchored hearing system)
Bone anchored hearing system for hearing rehabilitation

Locations

Country	Name	City	State
Denmark	Department of Oto-Rhino-Laryngology & Audiology Aalborg University Hospital	Aalborg
Denmark	Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant stability quotient (ISQ) at surgery	Initial implant stability measured directly after surgery	At surgery
Secondary	Surgical torque setting measured in Ncm	The surgical torque setting used to install the implant	At surgery
Secondary	Possibility to fit the sound processor, yes/no	Fitting of the sound processor at 5-12 days post-surgery	5-12 days post surgery
Secondary	Implant stability quotient (ISQ) after 12 months of follow up	Long term stability development	12 months post surgery
Secondary	Implant survivability measured as percentage successful implants after 12 months	Implant survivability	12 months post surgery