NCT01671176

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 7, 2018

Completed
Last Updated

May 7, 2018

Status Verified

April 1, 2018

Enrollment Period

2.5 years

First QC Date

August 15, 2012

Results QC Date

April 3, 2018

Last Update Submit

April 3, 2018

Conditions

Conductive Hearing LossConductive and Sensori-neural Hearing Loss in the Same EarUnilateral, Profound Sensori-neural Hearing Loss

Keywords

Wide diameter implantISQPontoBone anchored implant

Outcome Measures

Primary Outcomes (2)

  • Holger's Scale

    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

    1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months

  • Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane

    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.

    At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months

Study Arms (1)

Wide diameter bone anchored implant

OTHER

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

Interventions

Wide diameter bone anchored implantDEVICE

4.5 mm wide diameter bone anchored implant

Also known as: Oticon Medical Ponto Pro, Oticon Medical Ponto Pro Power, Osstell ISQ
Wide diameter bone anchored implant

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • younger than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Silverstein Institute

Sarasota, Florida, 34239, United States

Location

Michigan Ear Institute

Farmington Hills, Michigan, 48833, United States

Location

Related Publications (1)

  • Wazen JJ, Babu S, Daugherty J, Metrailer A. Three-week loading of the 4.5mm wide titanium implant in bone anchored hearing systems. Am J Otolaryngol. 2016 Mar-Apr;37(2):132-5. doi: 10.1016/j.amjoto.2015.08.005. Epub 2015 Aug 18.

    PMID: 26954868RESULT

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Ravi Sockalingam
Organization
Oticon Medical LLC
rsoc@oticomedical.com
9082023524

Study Officials

  • Jack Wazen, MD

    Sarasota Ear Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 15, 2012

First Posted

August 23, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 7, 2018

Results First Posted

May 7, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)