NCT03289845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

August 31, 2017

Last Update Submit

February 20, 2018

Conditions

Hearing Impaired (Partially)Hearing Impairment, ConductiveDeafness Unilateral

Outcome Measures

Primary Outcomes (1)

  • Implant stability quotient (ISQ) at surgery

    Initial implant stability measured directly after surgery

    At surgery

Secondary Outcomes (4)

  • Surgical torque setting measured in Ncm

    At surgery

  • Possibility to fit the sound processor, yes/no

    5-12 days post surgery

  • Implant stability quotient (ISQ) after 12 months of follow up

    12 months post surgery

  • Implant survivability measured as percentage successful implants after 12 months

    12 months post surgery

Study Arms (1)

BHX implant

OTHER

All patients implanted with BHX implant

Device: BHX implant (Bone anchored hearing system)

Interventions

BHX implant (Bone anchored hearing system)DEVICE

Bone anchored hearing system for hearing rehabilitation

BHX implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients eligible for treatment with a bone anchored hearing aid
  • years or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,

Hellerup, Copenhagen, 2900, Denmark

Location

Department of Oto-Rhino-Laryngology & Audiology Aalborg University Hospital

Aalborg, Denmark

Location

MeSH Terms

Conditions

Hearing LossHearing Loss, ConductiveHearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 21, 2017

Study Start

November 5, 2015

Primary Completion

January 4, 2016

Study Completion

December 1, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)