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Clinical Performance of a New Implant System for Bone Conduction Hearing

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ClinicalTrials.gov Identifier: NCT03086135
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions

Brief Summary:
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.

Condition or disease Intervention/treatment Phase
Deafness; Sensoneural Single Sided Conductive Hearing Loss Mixed Hearing Loss Device: Osia System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Performance of a New Implant System for Bone Conduction Hearing
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bone-conduction hearing device
The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Device: Osia System
An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.




Primary Outcome Measures :
  1. Hearing performance: threshold audiometry PTA4, unaided versus OSIA system at 3 months [ Time Frame: Baseline before surgery, 3 months after surgery ]
    The change of hearing performance with the OSIA system (aided) at 3 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).

  2. Speech in quiet at 65dB, unaided versus OSIA system at 3 months [ Time Frame: Baseline before surgery, 3 months after surgery ]
    The change of hearing performance [% correctly perceived words at 65dB SPL] with the OSIA System at 3 months compared to the pre-operative unaided situation; Speech in quiet at 65 dB SPL


Secondary Outcome Measures :
  1. Hearing performance: threshold audiometry PTA4, unaided versus OSIA system at 12 months [ Time Frame: Baseline before surgery, 12 months after surgery ]
    The change of hearing performance with the OSIA system (aided) at 12 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).

  2. Hearing performance: threshold audiometry individual frequences, unaided versus OSIA system [ Time Frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery ]
    The change of hearing performance with the OSIA system (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz).

  3. Speech in quiet at 50, 65 and 80 dB SPL, unaided versus OSIA system [ Time Frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery ]
    The change of hearing performance [% correctly perceived words at 50, 65 and 80 dB SPL] with the OSIA System compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80 dB SPL

  4. Adaptive Speech Recognition in Noise, unaided versus OSIA system [ Time Frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery ]
    The change of hearing performance with the OSIA System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio

  5. Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Baseline before surgery, 3 and 12 months after surgery ]
    Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the OSIA System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.

  6. Health Utility Index (HUI) [ Time Frame: Baseline before surgery, 3 and 12 months after surgery ]
    Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing OSIA System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.

  7. Speech, Spatial and Qualities of Hearing Scale (SSQ) [ Time Frame: Baseline before surgery, 3 and 12 months after surgery ]
    Measuring change of speech, spatial and hearing experiences with the OSIA System from the pe-operative unaided situation. A scale from 0 to 10 is used, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.

  8. Hearing performance: threshold audiometry PTA4, with reference device BP110 [ Time Frame: Baseline before surgery ]
    Hearing performance with the reference device BP110 on a softband (aided) before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).

  9. Hearing performance: threshold audiometry individual frequences with reference device BP110 [ Time Frame: Baseline before surgery ]
    Hearing performance with the reference device BP110 on a softband (aided); measured as free-field hearing tests: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz).

  10. Speech in quiet at 50, 65 and 80 dB SPL, with reference device BP110 [ Time Frame: Baseline before surgery ]
    Hearing performance [% correctly perceived words at 65dB SPL] with the reference device BP110 on a softband (aided); Speech in quiet at 50, 65 and 80 dB SPL

  11. Adaptive Speech Recognition in Noise, with reference device BP110 [ Time Frame: Baseline before surgery ]
    Hearing performance with the reference device BP110 on a softband (aided); Adaptive speech recognition in noise measured as signal to noise ratio

  12. Surgical information: time of surgery [ Time Frame: Visit 2, surgery ]
    Surgery time in minutes between first incision and last suture

  13. Surgical information: soft tissue thickness [ Time Frame: Visit 2, surgery ]
    Soft tissue thickness in mm

  14. Surgical information: soft tissue reduction [ Time Frame: Visit 2, surgery ]
    Yes or no

  15. Surgical information: bone polishing/temoval at Implant site [ Time Frame: Visit 2, surgery ]
    Yes or no

  16. Surgical information: type of anaesthesia [ Time Frame: Visit 2, surgery ]
    Type of anaesthesia: local or general

  17. Surgical information: Location of BI300 implant [ Time Frame: Visit 2, surgery ]
    Measured in mm from ear channel

  18. Surgical information: Incision type [ Time Frame: Visit 2, surgery ]
    Anterior based or posterior based flap

  19. Daily use of Sound Processor: usage time [ Time Frame: 6 weeks, 3, 6 and 12 months ]
    Usage time measured as hours per day

  20. Daily use of Sound Processor: comfort [ Time Frame: 6 weeks, 3, 6 and 12 months ]
    Measured with a visual analogue scale

  21. Magnet choice [ Time Frame: 4, 6 weeks, 3, 6 and 12 months ]
    Magnet strength: 1/2, 1, 2, 3, 4, 5 or 6

  22. Softpad use [ Time Frame: 6 weeks, 3, 6 and 12 months ]
    Yes or no



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adult subjects (18 years or older)
  • Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL.

OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but—for some reason—cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).

  • Signed informed consent
  • Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)

Exclusion Criteria:

  • Uncontrolled diabetes as judged by the investigator.
  • Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
  • Insufficient bone quality and quantity for implantation of a BI300 Implant.
  • Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
  • Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
  • Unable to follow investigational procedures, e.g. to complete quality of life scales.
  • Participation in another clinical investigation with pharmaceutical and/or device.

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): NCT03086135


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Australia, Victoria
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia, VIC 3002
Germany
University Medical Center Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Poland
World Hearing Center Institute of Physiology and Pathology of Hearing
Kajetany, Nadarzyn, Poland, 05-830
Sponsors and Collaborators
Cochlear Bone Anchored Solutions
Investigators
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Principal Investigator: Emmanuel Mylanus, Prof. Radboud Univerity Medical centre
Principal Investigator: Robert Briggs, Prof. The Royal Victorian Eye and Ear Hospita
Principal Investigator: Susan Arndt, Prof. Universitätsklinikum Freiburg
Principal Investigator: Piotr Skarżyński, Ass.Prof. Center of Hearing and Speech
Principal Investigator: Henry Alexander Arts, Prof. University of Michigan

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Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT03086135     History of Changes
Other Study ID Numbers: CBAS5539
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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