CompletedNCT03289845Updated Feb 22, 2018

Clinical Survey of Oticon Medical Ponto BHX Implant

An interventional study of BHX implant (Bone anchored hearing system) in Hearing Impaired (Partially), Hearing Impairment, Conductive and Deafness Unilateral, sponsored by Oticon Medical. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Oticon Medical · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Hearing Impaired (Partially)
Hearing Impairment, Conductive
Deafness Unilateral

Browse trials for

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 36 participants (actual)

Study arms

Other
BHX implant
All patients implanted with BHX implant
Device: BHX implant (Bone anchored hearing system)

Interventions

DeviceBHX implant (Bone anchored hearing system)
Bone anchored hearing system for hearing rehabilitation

What researchers measure

Primary outcomes

Implant stability quotient (ISQ) at surgery
Initial implant stability measured directly after surgery
Time frame: At surgery

Secondary outcomes

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

Study locations

2 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03289845
Lead sponsor: Oticon Medical
Responsible party: Sponsor
First posted: Sep 21, 2017
Start date: Nov 5, 2015
Primary completion: Jan 4, 2016
Completion: Dec 2017
Last update: Feb 22, 2018

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Deafness→

Other studies from this sponsor

Oticon Medical

Start the discussion