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.

Primary conditionHearing Loss, UnilateralRegistry: Hearing LossReclassifiedWhy we changed it

Registry

Hearing Loss — the first condition term the registry derived for this study.

ClinicalTrials.gg

Hearing Loss, Unilateral

Why

The study's listed conditions name Hearing Loss, Unilateral, a narrower term within Hearing Loss.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

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

From the registry’s dates

Registered 1 year 9 months after the study started (first participant enrolled Nov 2015, registered Aug 2017).

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

Hearing Loss 796Registry's first term
Hearing Loss, Conductive 82
Hearing Loss, Unilateral 51Primary · reclassified

In context

Hearing Loss, Unilateral Reclassified

51 studies on the registry are indexed under Hearing Loss, Unilateral; 7 are open to participants now.

This study's enrollment of 36 is close to the median of 35 across 35 interventional studies indexed under Hearing Loss, Unilateral.

Browse Hearing Loss, Unilateral studies →

Lead sponsor

Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Browse Oticon Medical studies →

Compared within Hearing Loss, Unilateral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2015 to primary completion in Jan 2016, 1 month.

Of 24 interventional studies with no phase under Hearing Loss, Unilateral, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 83. This study's 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 31, 2017
First posted: Sep 21, 2017
StartActual: Nov 5, 2015
Primary completionActual: Jan 4, 2016
CompletionActual: Dec 2017
Last update: Feb 22, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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.

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Discussion

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