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Home Test of New Sound Processor

Primary Purpose

Hearing Loss

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

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Conductive Hearing Loss, Mixed Hearing Loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult subject (18-<70 years of age)
  • At least 12 months experience from using a Baha Connect system (percutaneous Baha)
  • Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Signs of infection around the implant site
  • Unable to follow investigational procedures
  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
  • Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  • Cochlear employees
  • Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Sites / Locations

  • Cochlear Bone Anchored Solutions AB (CBAS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

New SP followed by Baha 5 SP followed by single blinded SP

Baha 5 SP followed by the New SP followed by single blinded SP

Arm Description

Aided hearing with new Sound Processor followed by aided hearing with the Baha 5 sound processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).

Aided hearing with Baha 5 sound processor followed by aided hearing with the new Sound Processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).

Outcomes

Primary Outcome Measures

Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF

Secondary Outcome Measures

Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor.
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB SPL and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz]
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet
Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words.
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Participant rating on a likert scale from 1-5 where 1 represents the most negative and 5 represents the most positive experience of loudness, sound quality, sound clarity, speech understanding, presence of artefacts after listening to sound clips.
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Participant rating Yes or No for internal noise after listening to sound clips.
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.
Participant rating for listening effort assessed with the Borg scale. The Borg scale measures the level of effort it takes trying to hear what is said in a sound clip. The scale is from 0-10 where 0= no effort at all and 10=maximal effort.
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz]
Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet
Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words

Full Information

First Posted
September 16, 2020
Last Updated
October 21, 2021
Sponsor
Cochlear
Collaborators
Statistiska Konsultgruppen
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1. Study Identification

Unique Protocol Identification Number
NCT04559282
Brief Title
Home Test of New Sound Processor
Official Title
A Pivotal, Prospective, Single-centre, Randomized Test Order, Crossover, Open Label Study Comparing the Performance of a New Sound Processor With Unaided Hearing and Baha 5 in Adult Subjects With Conductive or Mixed Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
Statistiska Konsultgruppen

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
The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New SP followed by Baha 5 SP followed by single blinded SP
Arm Type
Experimental
Arm Description
Aided hearing with new Sound Processor followed by aided hearing with the Baha 5 sound processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).
Arm Title
Baha 5 SP followed by the New SP followed by single blinded SP
Arm Type
Experimental
Arm Description
Aided hearing with Baha 5 sound processor followed by aided hearing with the new Sound Processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).
Intervention Type
Device
Intervention Name(s)
New Sound Processor
Intervention Description
The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.
Primary Outcome Measure Information:
Title
Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
Description
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Time Frame
Day 0, day 7 and day 14
Title
Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Description
Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor.
Time Frame
Day 7 and day 14
Title
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise
Description
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB SPL and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Time Frame
Day 0 and day 7
Title
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
Description
Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz]
Time Frame
Day 0 and day 7
Title
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet
Description
Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words.
Time Frame
Day 0 and day 7
Title
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Description
Participant rating on a likert scale from 1-5 where 1 represents the most negative and 5 represents the most positive experience of loudness, sound quality, sound clarity, speech understanding, presence of artefacts after listening to sound clips.
Time Frame
Day 14
Title
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Description
Participant rating Yes or No for internal noise after listening to sound clips.
Time Frame
Day 14
Title
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.
Description
Participant rating for listening effort assessed with the Borg scale. The Borg scale measures the level of effort it takes trying to hear what is said in a sound clip. The scale is from 0-10 where 0= no effort at all and 10=maximal effort.
Time Frame
Day 14
Title
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
Description
Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz]
Time Frame
Day 0, day 7 and day 14
Title
Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet
Description
Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words
Time Frame
Day 0, day 7 and day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subject (18-<70 years of age) At least 12 months experience from using a Baha Connect system (percutaneous Baha) Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist Willing and able to provide written informed consent Exclusion Criteria: Signs of infection around the implant site Unable to follow investigational procedures Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Ganlöv, MD
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
Cochlear Bone Anchored Solutions AB (CBAS)
City
Mölnlycke
ZIP/Postal Code
SE-435 33
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

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Home Test of New Sound Processor

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