Clinical Survey of Oticon Medical Ponto BHX Implant

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.

Study Overview

• Status: Completed
• Conditions: Hearing Impairment, Conductive; Deafness Unilateral; Hearing Impaired (Partially)
• Intervention / Treatment: Device: BHX implant (Bone anchored hearing system)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Department of Oto-Rhino-Laryngology & Audiology Aalborg University Hospital
  • Copenhagen
    • Hellerup, Copenhagen, Denmark, 2900
      • Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BHX implant; All patients implanted with BHX implant	Device: BHX implant (Bone anchored hearing system); Bone anchored hearing system for hearing rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability quotient (ISQ) at surgery	Initial implant stability measured directly after surgery	At surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oticon Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2015
• Primary Completion (Actual): January 4, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Unilateral
• Other Study ID Numbers: C55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No