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CompletedNCT01738490Updated Nov 27, 2017

Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

An interventional study of Bone anchored hearing implant in Deafness, Hearing Loss and Hearing Loss, Conductive, sponsored by Oticon Medical. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-27.

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

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed.

More specifically the primary objective of this clinical study is to test the hypothesis

  • The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.

And the secondary objective is to

  • Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability
02

Conditions studied

  • Deafness
  • Hearing Loss
  • Hearing Loss, Conductive
  • Hearing Disorders
  • Ear Diseases
  • Otorhinolaryngologic Diseases

Keywords

  • Bone anchored hearing aid
  • Bone anchored implant
  • Implant stability
  • Wide diameter implant
  • Linear incision
  • Ponto
03

In context

Deafness

160 studies on the registry are indexed under Deafness; 46 are open to participants now.

This study's enrollment of 59 is above the median of 43 across 106 interventional studies indexed under Deafness.

Browse Deafness 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 →

Counted across the registry records on this site, refreshed daily.

04

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

  • 18 years or older
  • Patient indicated for an ear level bone anchored sound processor
  • Bone thickness at the implant site of at least 4 mm

Exclusion criteria

Exclusion Criteria:

  • Longer abutment (>6mm) required
  • Inability to participate in follow-up
  • Psychiatric disease in the medical history
  • Mental disability
  • Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
  • Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Other
    Wide diameter implant

    Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed.

    Device: Bone anchored hearing implant

  • Other
    Control group

    Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.

    Device: Bone anchored hearing implant

Interventions

  • DeviceBone anchored hearing implant

    Also known as: Ponto implant, Bone anchored hearing aid

06

What researchers measure

Primary outcomes

  1. ISQ (Implant Stability Quotient)

    ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability. The measurement is made using the Osstell Mentor equipment (Osstell, Sweden) with SmartPegs. ISQ values range from 1 to 100, the higher the score the higher the stability. The highest and lowest score obtained from perpendicular measurements will be registered.

    Time frame: Surgery (0 days)

  2. ISQ (Implant Stability Quotient)

    Time frame: 7 days after surgery

  3. ISQ (Implant Stability Quotient)

    Time frame: 14 days after surgery

  4. ISQ (Implant Stability Quotient)

    Time frame: 21 days after surgery

  5. ISQ (Implant Stability Quotient)

    Time frame: 28 days after surgery

  6. ISQ (Implant Stability Quotient)

    Time frame: 6 weeks after surgery

  7. ISQ (Implant Stability Quotient)

    Time frame: 12 weeks after surgery

  8. ISQ (Implant Stability Quotient)

    Time frame: 6 months after surgery

  9. ISQ (Implant Stability Quotient)

    Time frame: 12 months after surgery

  10. ISQ (Implant Stability Quotient)

    Time frame: 24 months after surgery

  11. ISQ (Implant Stability Quotient)

    Time frame: 36 months after surgery

Secondary outcomes

  1. Time of minimum ISQ (Implant stability quotient)

    Implant stability can be seen as a combination of mechanical stability, which is the result of compressed bone holding the implant tightly in place, and biological stability, which is the result of new bone forming at the site of implantation and osseointegration. Mechanical stability is generally high immediately after implant placement and is decreasing with time. Biological stability, on the other hand, is non-existent immediately after placement and increases with time. The final stability level for an implant is the sum of the two. There is likely to be an initial decrease in stability followed by a subsequent increase as the implant becomes biologically stable. ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability.

    Time frame: 0, 7, 14, 21 and 28 days after surgery

  2. ISQ (Implant stability quotient) gradient

    ISQ (implant stability quotient) per time unit gives a measure of osseointegration speed.

    Time frame: 0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery

  3. Skin condition according to Holgers score

    Holgers score is a standardized scale to clinically assess skin condition around a percutaneous implant

    Time frame: 7 days after surgery

  4. Skin condition according to Holgers score

    Time frame: 14 days after surgery

  5. Skin condition according to Holgers score

    Time frame: 21 days after surgery

  6. Skin condition according to Holgers score

    Time frame: 28 days after surgery

  7. Skin condition according to Holgers score

    Time frame: 6 weeks after surgery

  8. Skin condition according to Holgers score

    Time frame: 12 weeks after surgery

  9. Skin condition according to Holgers score

    Time frame: 6 months after surgery

  10. Skin condition according to Holgers score

    Time frame: 12 months after surgery

  11. Skin condition according to Holgers score

    Time frame: 24 months after surgery

  12. Skin condition according to Holgers score

    Time frame: 36 months after surgery

  13. Glasgow Benefit Inventory Questionnaire

    Glasgow Benefit Inventory Questionnaire (GBI) 18-item, post-surgical questionnaire given to patients. The GBI measures the change in health status produced by surgical interventions (here, "health status" is the general perception of well-being, including total psychological, social, and physical well being).

    Time frame: 3 months after surgery

  14. Glasgow Benefit Inventory Questionnaire

    Time frame: 12 months after surgery

  15. Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

    The APHAB is a 24-item self-assessment inventory in which patients report the amount of trouble they are having with communication or noises in various everyday situations. Benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).

    Time frame: Before surgery

  16. Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

    Time frame: 6 months after surgery

  17. Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire

    Time frame: 36 months after surgery

  18. Glasgow Health Status Inventory (GHSI) questionnaire

    The Glasgow Health Status Inventory is an 18 item questionnaire. It assesses health state, by measuring the effect of a health problem on the quality of life of a person. It allows cross-comparison among many health conditions, among different health interventions, and among demographic and cultural subgroups.

    Time frame: Before surgery

  19. Glasgow Health Status Inventory (GHSI) questionnaire

    Time frame: 6 months after surgery

  20. Glasgow Health Status Inventory (GHSI) questionnaire

    Time frame: 36 months after surgery

07

Study locations

1 site
  • University Medical Center St Radboud
    Nijmegen, 6500, Netherlands
08

References and documents

Publications

  • Nelissen RC, den Besten CA, Mylanus EA, Hol MK. Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial. Eur Arch Otorhinolaryngol. 2016 Jan;273(1):105-11. doi: 10.1007/s00405-015-3593-x. Epub 2015 Mar 20. Erratum In: Eur Arch Otorhinolaryngol. 2016 Jan;273(1):113-4. doi: 10.1007/s00405-015-3798-z. PubMed 25790770 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2012, a primary completion of Jun 2014 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

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

Registered
Nov 28, 2012
First posted
Nov 30, 2012
Start
Jun 2012
Primary completionActual
Jun 2014
CompletionActual
Dec 2016
Last update
Nov 27, 2017
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 Nov 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01738490
Lead sponsor
Oticon Medical
Responsible party
Sponsor
First posted
Nov 30, 2012
Start date
Jun 2012
Primary completion
Jun 2014
Completion
Dec 2016
Last update
Nov 27, 2017

Study contacts

Myrthe KS Hol, MD, PhD
principal investigator · University Medical Center St Radboud, Nijmegen, The Netherlands

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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