Home Test of New Sound Processor

A study testing New Sound Processor in people with Hearing Loss, run by Cochlear at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hearing Loss
What is being tested?: New Sound Processor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSweden
Study dates: 23 Sep 2020to 27 Nov 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Cochlear Bone Anchored Solutions AB (CBAS)
Mölnlycke, SE-435 33

Other trials in Sweden

About this study

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

Conditions: Hearing Loss
Being tested: New Sound Processor
Keywords: Conductive Hearing Loss, Mixed Hearing Loss
Medical subject headings: Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New Sound ProcessorDevice
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.

Study groups in NCT04559282
Study group	Role	What they receive
New SP followed by Baha 5 SP followed by single blinded SP	Experimental	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). Receives: Device: New Sound Processor
Baha 5 SP followed by the New SP followed by single blinded SP	Experimental	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). Receives: Device: New Sound Processor

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 0, day 7 and day 14
Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF
Measured: Day 14

Secondary outcomes (9)

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.
Measured: Day 7 and day 14
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
Measured: Day 0 and day 7
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]
Measured: Day 0 and day 7
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.
Measured: Day 0 and day 7
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.
Measured: Day 14
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.
Measured: Day 14
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.
Measured: Day 14
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]
Measured: Day 0, day 7 and day 14
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
Measured: Day 0, day 7 and day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 202027 Nov 2020

First posted22 Sep 2020
Study start23 Sep 2020
Primary completion27 Nov 2020
Study completion27 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04559282
Sponsor's protocol ID: CBAS5779
Status last verified: Dec 2020
First submitted: 16 Sep 2020
Last updated: 22 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness

All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04559282
Acronym / sponsor ID: CBAS5779
Conditions: Hearing Loss
Keywords: Conductive Hearing Loss, Mixed Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Collaborators: Statistiska Konsultgruppen
Study start: 23 Sep 2020 (actual)
Primary completion: 27 Nov 2020 (actual)
Study completion: 27 Nov 2020 (actual)
First posted: 22 Sep 2020 (actual)
Results: Posted 22 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
New SP followed by Baha 5 SP followed by single blinded SP	Experimental	Device: New Sound ProcessorAided 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).
Baha 5 SP followed by the New SP followed by single blinded SP	Experimental	Device: New Sound ProcessorAided 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).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
New Sound ProcessorThe 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.	Device	Baha 5 SP followed by the New SP followed by single blinded SP, New SP followed by Baha 5 SP followed by single blinded SP

Primary outcome

Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
Time frame: Day 0, day 7 and day 14
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
Time frame: Day 14

9 secondary outcomes

Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Time frame: Day 7 and day 14
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise
Time frame: Day 0 and day 7
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
Time frame: Day 0 and day 7
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet
Time frame: Day 0 and day 7
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Time frame: Day 14
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Time frame: Day 14
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.
Time frame: Day 14
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
Time frame: Day 0, day 7 and day 14
Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet
Time frame: Day 0, day 7 and day 14

Results and safety

Results posted to the registry on 22 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baha 6 Max Followed by Baha 5 SP Followed by Unaided Hearing	8	8
Baha 5 SP Followed by Baha 6 Max Followed by Unaided Hearing	8	8

Primary outcome: Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise

Time frame: Day 0, day 7 and day 14. Mean (Standard Deviation). Unit: db SNR (decibel Speech in Noise Ratio)

Measure	Baha 6 Max n = 16	Unaided n = 16
Value	-3.7 (2.75)	4.8 (6.55)

Population analysed: Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants.

Primary outcome: Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF

Time frame: Day 14. Count of participants. Unit: Participants

Measure	Baha 6 Max n = 16	Baha 5 n = 16
Value	13	3

Population analysed: Participants received Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baha 6 Max	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Baha 5	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Unaided	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. 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.

Related trials for Hearing Loss

Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karin Ganlöv, MD study director

Cochlear

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing New Sound Processor in people with Hearing Loss, run by Cochlear at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise (time frame: Day 0, day 7 and day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04559282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.