Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03289845
NCT03289845CompletedNot Applicable

Clinical Survey of Oticon Medical Ponto BHX Implant

Oticon Medical3 sites in 1 country36 target enrollmentStarted: November 5, 2015Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
3
Primary Endpoint
Implant stability quotient (ISQ) at surgery
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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.

Outcomes

Primary Outcomes

Implant stability quotient (ISQ) at surgery

Time Frame: At surgery

Initial implant stability measured directly after surgery

Secondary Outcomes

  • Surgical torque setting measured in Ncm(At surgery)
  • Implant stability quotient (ISQ) after 12 months of follow up(12 months post surgery)
  • Implant survivability measured as percentage successful implants after 12 months(12 months post surgery)
  • Possibility to fit the sound processor, yes/no(5-12 days post surgery)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

Loading locations...

Similar Trials

Completed
Not Applicable
Wide Diameter Bone Anchored Implant StudyConductive Hearing LossConductive and Sensori-neural Hearing Loss in the Same EarUnilateral, Profound Sensori-neural Hearing Loss
NCT01671176Oticon Medical30
Completed
Not Applicable
Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue PreservationConductive Hearing LossMixed Hearing LossSingle Sided Deafness
NCT02064478Oticon Medical25
Withdrawn
Phase 4
Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)Conductive Hearing LossMixed Hearing LossUnilateral Deafness
NCT01264510University Hospital, Ghent
Recruiting
Not Applicable
Evaluation of 3D printed bone implant in skull and the face surgeryZ96.7Absorbable bone implants to correct craniofacial abnormalities.Presence of other bone and tendon implants
IRCT20220807055633N1Esfahan University of Medical Sciences7
Completed
Not Applicable
Bone Anchored Hearing Implants in Chronic Otitis MediaHearing
NCT06047639Pamukkale University24