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Wide Diameter Bone Anchored Implant Study

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ClinicalTrials.gov Identifier: NCT01671176
Recruitment Status : Completed
First Posted : August 23, 2012
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

Brief Summary:
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to determine the feasibility of fitting the sound processor 3 weeks after surgical implantation, and to investigate if the type of skin reactions following implantation could be related to the demographic data of subjects and the type of surgical technique used

Condition or disease Intervention/treatment Phase
Conductive Hearing Loss Conductive and Sensori-neural Hearing Loss in the Same Ear Unilateral, Profound Sensori-neural Hearing Loss Device: Wide diameter bone anchored implant Not Applicable

Detailed Description:

Bone-anchored hearing systems have been an amplification choice for conductive, mixed, and profound, unilateral, sensorineural hearing loss for over three decades. So far, about 75,000 patients worldwide have received this surgical intervention (bone-anchored hearing system), since its first successful implantation in 1977. In 2009, Oticon Medical, LLC launched its bone-anchored hearing system called Ponto. In just over two years, the Ponto has been successfully implanted in over 3,000 patients by leading otolaryngologists and neurotologists in 18 countries worldwide.

The Ponto implant has previously been available with a 3.75mm diameter and comes in two lengths: 3mm and 4mm. Anew Ponto implant that is 4.5mm wide in diameter is now available in both 3mm and 4mm lengths. This Wide Diameter implant is designed to maximize bone-to-implant contact area and enhance implant stability which can potentially allow loading of the sound processor as early as 3 weeks after surgery. The abutment screw incorporates external threads at the screw head to make it possible to connect a SmartPeg (Osstell, Goteborg, Sweden) for stability measurements. All Ponto implants have the same universal implant-abutment interface. Therefore, they are fully compatible with existing instruments and abutments. Two new countersinks have been developed for the new Ponto Wide Diameter implant. The drill size of the countersink is 3.80mm. It is marked with a "W" to separate them from existing drills. All products are CE-marked and cleared for the US market by the FDA.

Objectives The present study will attempt to show that the Ponto 4.5mm Wide Diameter implant has similar or better outcomes in terms of Quality of Life (QoL) benefit; implant extrusion and revision surgery when compared to the 3.75mm diameter implant. Secondary objectives to be studied will include adverse skin reactions, the feasibility of fitting the sound processor three weeks after surgical implantation, and investigation to see if the type of skin reactions observed following implantation could be related to the demographic data of subjects or the type of surgical technique used.

Study Design This study is a prospective, multicenter study of subjects' demographic and implant data. Subjects will be enrolled at two US sites.

Subject Population Twenty adult subjects 18 years or older will be included in the study from each participating partner site.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of the Oticon Medical Ponto 4.5mm Wide Implant
Study Start Date : May 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Wide diameter bone anchored implant
Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
Device: Wide diameter bone anchored implant
4.5 mm wide diameter bone anchored implant
Other Names:
  • Oticon Medical Ponto Pro
  • Oticon Medical Ponto Pro Power
  • Osstell ISQ



Primary Outcome Measures :
  1. Holger's Scale [ Time Frame: 1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months ]
    Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery

  2. Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane [ Time Frame: At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months ]
    Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • conductive, mixed or single sided deafness
  • 18 years of age or older

Exclusion Criteria:

  • younger than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671176


Locations
United States, Florida
Silverstein Institute
Sarasota, Florida, United States, 34239
United States, Michigan
Michigan Ear Institute
Farmington Hills, Michigan, United States, 48833
Sponsors and Collaborators
Oticon Medical
Investigators
Principal Investigator: Jack Wazen, MD Sarasota Ear Institute

Publications of Results:
Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT01671176     History of Changes
Other Study ID Numbers: Wide04262012
First Posted: August 23, 2012    Key Record Dates
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Oticon Medical:
Wide diameter implant
ISQ
Ponto
Bone anchored implant

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Loss, Sensorineural
Retrocochlear Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms