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Evaluation of Sound Processor for a Transcutaneous System

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ClinicalTrials.gov Identifier: NCT03374787
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Oticon Medical

Study Description
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Brief Summary:
A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires.

Condition or disease Intervention/treatment Phase
Conductive Hearing Loss Mixed Hearing Loss Device: Fusion Sound Processor Not Applicable

Detailed Description:
Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Single Center Evaluation of a Sound Processor for a Transcutaneous System
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : November 22, 2018
Actual Study Completion Date : November 22, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fusion sound processor
The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
 Device: Fusion Sound Processor
Sound Processor


Outcome Measures
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Primary Outcome Measures :
  1. Aided thresholds Fusion-unaided PTA [ Time Frame: 6 months ]
    Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)


Secondary Outcome Measures :
  1. Aided thresholds Fusion-unaided [ Time Frame: 6 months ]
    Difference between Fusion-aided and unaided sound field Pure Tone thresholds at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz

  2. Aided thresholds Fusion PTA4 [ Time Frame: Baseline, 1 and 6 month(s) ]
    Difference between Fusion-aided sound field PTA4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)

  3. Aided thresholds Fusion [ Time Frame: Baseline, 1 and 6 month(s) ]
    Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at

  4. Aided thresholds Fusion-BCI PTA4 [ Time Frame: 6 months ]
    Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)

  5. Aided thresholds Fusion-BCI [ Time Frame: 6 months ]
    Difference between Fusion-aided and BCI-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz

  6. Speech intelligibility Fusion-unaided % [ Time Frame: 6 months ]
    Difference between Fusion-aided and unaided speech intelligibility scores (in % correct)

  7. Speech intelligibility Fusion-unaided signal to noise ratio (SNR) [ Time Frame: 6 months ]
    Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR

  8. Speech intelligibility Fusion % [ Time Frame: Baseline, 1 and 6 month(s) ]
    Difference between Fusion-aided speech intelligibility scores (in % correct)

  9. Speech intelligibility Fusion SNR [ Time Frame: Baseline, 1 and 6 month(s) ]
    Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR

  10. Speech intelligibility Fusion-BCI % [ Time Frame: 6 months ]
    Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct)

  11. Speech intelligibility Fusion-BCI SNR [ Time Frame: 6 months ]
    Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR

  12. Magnet strength [ Time Frame: Baseline, 1 and 6 month(s) ]
    Difference in magnet strength measured on the patient's heads in Newton

  13. IPS (Inflammation, Pain, Skin height/numbness) evaluation [ Time Frame: Baseline, 1 and 6 month(s) ]
    Combined score of IPS evaluating the skin area under the sound processor. I scale ranging from 0-4, Pain scale ranging from 0-2, Skin height/numbness ranging from 0-2. Total score 0-8 (0 no adverse skin condition, 8 maximum adverse skin reactions on all subscales)

  14. Subjective evaluation [ Time Frame: Baseline, 1 and 6 month(s) ]
    User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor

  15. Subjective evaluation SSQ [ Time Frame: Baseline, 1 and 6 month(s) ]
    Subjective performance as measured by Speech, Spatial and Quality (SSQ) a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect"


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects implanted with the Bridging Bone Conductor (BBC) implant
  • Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
  • Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
  • Active user of the BCI SP

Exclusion Criteria:

  • Inability to participate in follow-ups
  • Unsuitable as judged by the principle investigator or the sub-investigator
Contacts and Locations
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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): NCT03374787


Locations
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Sweden
ENT departement, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 46
Sponsors and Collaborators
Oticon Medical
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Måns Eeg Olofsson, MD Sahlgrenska University Hospital, Sweden
More Information
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Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT03374787    
Other Study ID Numbers: C58
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 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: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
 Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases