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OpenTrials
Completed

NCT Number: NCT03289845

Clinical Survey of Oticon Medical Ponto BHX Implant

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.

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Key information

Conditions

Hearing Impaired (Partially) Deafness Unilateral Ear Diseases Hearing Disorders Hearing Impairment, Conductive Hearing Loss Hearing Loss, Conductive Hearing Loss, Unilateral Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,, Hellerup, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BHX implant (Bone anchored hearing system)

Device

Bone anchored hearing system for hearing rehabilitation

Primary outcomes

  1. Implant stability quotient (ISQ) at surgery

    Time frame: At surgery

    Initial implant stability measured directly after surgery

Secondary outcomes

  1. Surgical torque setting measured in Ncm

    Time frame: At surgery

    The surgical torque setting used to install the implant

  2. Possibility to fit the sound processor, yes/no

    Time frame: 5-12 days post surgery

    Fitting of the sound processor at 5-12 days post-surgery

  3. Implant stability quotient (ISQ) after 12 months of follow up

    Time frame: 12 months post surgery

    Long term stability development

  4. Implant survivability measured as percentage successful implants after 12 months

    Time frame: 12 months post surgery

    Implant survivability

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 21, 2017
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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