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Evaluation of Sound Processor for a Transcutaneous System

Primary Purpose

Conductive Hearing Loss, Mixed Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Fusion Sound Processor
Sponsored by
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Conductive Hearing Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ENT departement, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fusion sound processor

Arm Description

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.

Outcomes

Primary Outcome Measures

Aided thresholds Fusion-unaided PTA
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

Aided thresholds Fusion-unaided
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
Aided thresholds Fusion PTA4
Difference between Fusion-aided sound field PTA4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
Aided thresholds Fusion
Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at
Aided thresholds Fusion-BCI PTA4
Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)
Aided thresholds Fusion-BCI
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
Speech intelligibility Fusion-unaided %
Difference between Fusion-aided and unaided speech intelligibility scores (in % correct)
Speech intelligibility Fusion-unaided signal to noise ratio (SNR)
Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR
Speech intelligibility Fusion %
Difference between Fusion-aided speech intelligibility scores (in % correct)
Speech intelligibility Fusion SNR
Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR
Speech intelligibility Fusion-BCI %
Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct)
Speech intelligibility Fusion-BCI SNR
Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR
Magnet strength
Difference in magnet strength measured on the patient's heads in Newton
IPS (Inflammation, Pain, Skin height/numbness) evaluation
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)
Subjective evaluation
User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor
Subjective evaluation SSQ
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"

Full Information

First Posted
December 4, 2017
Last Updated
April 23, 2019
Sponsor
Oticon Medical
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03374787
Brief Title
Evaluation of Sound Processor for a Transcutaneous System
Official Title
Single Center Evaluation of a Sound Processor for a Transcutaneous System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
November 22, 2018 (Actual)
Study Completion Date
November 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conductive Hearing Loss, Mixed Hearing Loss

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fusion sound processor
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fusion Sound Processor
Intervention Description
Sound Processor
Primary Outcome Measure Information:
Title
Aided thresholds Fusion-unaided PTA
Description
Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Aided thresholds Fusion-unaided
Description
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
Time Frame
6 months
Title
Aided thresholds Fusion PTA4
Description
Difference between Fusion-aided sound field PTA4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
Time Frame
Baseline, 1 and 6 month(s)
Title
Aided thresholds Fusion
Description
Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at
Time Frame
Baseline, 1 and 6 month(s)
Title
Aided thresholds Fusion-BCI PTA4
Description
Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)
Time Frame
6 months
Title
Aided thresholds Fusion-BCI
Description
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
Time Frame
6 months
Title
Speech intelligibility Fusion-unaided %
Description
Difference between Fusion-aided and unaided speech intelligibility scores (in % correct)
Time Frame
6 months
Title
Speech intelligibility Fusion-unaided signal to noise ratio (SNR)
Description
Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR
Time Frame
6 months
Title
Speech intelligibility Fusion %
Description
Difference between Fusion-aided speech intelligibility scores (in % correct)
Time Frame
Baseline, 1 and 6 month(s)
Title
Speech intelligibility Fusion SNR
Description
Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR
Time Frame
Baseline, 1 and 6 month(s)
Title
Speech intelligibility Fusion-BCI %
Description
Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct)
Time Frame
6 months
Title
Speech intelligibility Fusion-BCI SNR
Description
Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR
Time Frame
6 months
Title
Magnet strength
Description
Difference in magnet strength measured on the patient's heads in Newton
Time Frame
Baseline, 1 and 6 month(s)
Title
IPS (Inflammation, Pain, Skin height/numbness) evaluation
Description
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)
Time Frame
Baseline, 1 and 6 month(s)
Title
Subjective evaluation
Description
User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor
Time Frame
Baseline, 1 and 6 month(s)
Title
Subjective evaluation SSQ
Description
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"
Time Frame
Baseline, 1 and 6 month(s)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Måns Eeg Olofsson, MD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
ENT departement, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 46
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Sound Processor for a Transcutaneous System

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