Clinical Survey of Oticon Medical Ponto BHX Implant | NCT03289845

Studies
Clinical Survey of Oticon Medical Ponto BHX Implant

NCT03289845

Sponsor

Oticon Medical

Status

Completed

Last Update Posted

Feb 22, 2018Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Hearing Impaired (Partially)
Hearing Impairment, Conductive
Deafness Unilateral

Interventions

BHX implant (Bone anchored hearing system)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2015Actual

Primary Completion Date

Jan 4, 2016Actual

Completion Date

Dec 2017Actual

First Submitted Date

Aug 31, 2017

First Submission Date that Met QC Criteria

Sep 18, 2017

First Posted Date

Sep 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2018

Last Update Posted Date

Feb 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BHX implant	Other	All patients implanted with BHX implant	Device: BHX implant (Bone anchored hearing system)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BHX implant (Bone anchored hearing system)	Device	Bone anchored hearing system for hearing rehabilitation	BHX implant

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,		Hellerup	Copenhagen	2900	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss
D006314	Hearing Loss, Conductive
D046088	Hearing Loss, Unilateral

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided