Sensorineural Hearing LossFASTNCT02698787

Fundamental Asynchronous Stimulus Timing Sound Coding Study

A study testing Experimental sound coding strategy (FAST) and Commercially available ACE sound coding strategy in people with Sensorineural Hearing Loss, run by Cochlear at 1 site in United States.

Completed

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

Official record

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Trial summary

The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sensorineural Hearing Loss
What is being tested?: Experimental sound coding strategy (FAST) and Commercially available ACE sound coding strategy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Dec 2015to 19 Nov 2018
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Medical and audiological candidate for a unilateral CI24RE, CI512 or CI532 series implant
Post-linguistically deafened
Native speaker of American English
Eighteen years of age or older

Who cannot join

Previous or existing cochlear-implant recipient
Pre-linguistically deafened (onset of hearing loss at less than two years of age)
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
Diagnosis of retro-cochlear pathology
Diagnosis of auditory neuropathy
Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
Unwillingness or inability to comply with all investigational requirements
Additional cognitive handicaps that would delay rate of improvement with the cochlear implant

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Health
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients

Read the detailed description

The Fundamental Asynchronous Stimulus Timing (FAST) strategy offers excellent potential as a low power alternative coding strategy to the current default strategy in Nucleus® cochlear implants, Advanced Combination Encoder (ACE). Additionally, FAST offers potential bilateral benefits - localization and listening in spatially separated noise - because it has been shown in acute, controlled studies to provide more access to interaural timing difference (ITD) cues (Smith, 2010).Previous research with experienced cochlear-implant recipients has shown issues with conversion from ACE to FAST. The FAST strategy typically sounds very different in quality, and acclimatization can be lengthy. This extended adaptation time makes it difficult to show conclusively that FAST is non-inferior to ACE for speech understanding. A potential barrier to evaluating performance with FAST in current cochlear-implant recipients is the extensive amount of prior experience that many recipients have using ACE. Hence, there is a distinct need to evaluate FAST in newly implanted recipients.

Conditions: Sensorineural Hearing Loss
Being tested: Experimental sound coding strategy (FAST), Commercially available ACE sound coding strategy
Keywords: cochlear implant, sensorineural hearing loss
Medical subject headings: Hearing Loss, Sensorineural

What participants receive

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

Experimental sound coding strategy (FAST)Device
Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
Commercially available ACE sound coding strategyDevice
Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy

Study groups in NCT02698787
Study group	Role	What they receive
Group 1	Experimental	All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy. Receives: Device: Experimental sound coding strategy (FAST); Device: Commercially available ACE sound coding strategy
Group 2	Experimental	All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation. Receives: Device: Experimental sound coding strategy (FAST); Device: Commercially available ACE sound coding strategy

What is being measured

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

Change in Open Set Monosyllabic Word Recognition Score
Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct.
The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct.
Measured: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)
Change in Signal-to-Noise Ratio (SRT)
The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance.
SRT measures are obtained using two types of background noise. One is "Speech-Shaped Noise" which is white noise or tones made to mimic speech. The other is "Four-Talker Noise" which is multiple talkers made to mimic background conversation.
Measured: Visit 5 (3 Months) and Visit 8 (6 months)

Timeline

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

Dec 201519 Nov 2018

First posted4 Mar 2016 (estimated)
Study startDec 2015
Primary completion19 Nov 2018
Study completion19 Nov 2018

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.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Sensorineural 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02698787
Sponsor's protocol ID: CAM5621
Acronym: FAST
Status last verified: Jan 2021
First submitted: 3 Dec 2015
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Daneman , M., & Carpenter, P.A. (1980). Individual differences in working memory and reading. Journal of Verbal Learning andVerbal Behavior, 19, 450-466.
Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. 2013 Jun;52(6):409-12. doi: 10.3109/14992027.2013.781278.
PubMed 23651462
Bench J, Kowal A, Bamford J. The BKB (Bamford-Kowal-Bench) sentence lists for partially-hearing children. Br J Audiol. 1979 Aug;13(3):108-12. doi: 10.3109/03005367909078884.
PubMed 486816
PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
PubMed 14485785
Smith, Z. M. (2010). Improved sensitivity to interaural time differences with the FAST coding strategy. Presented at the 11th International Conference on Cochlear Implants and Other Implantable Auditory Technologies, Stockholm, Sweden.

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

Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Active, not recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Active, not recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural, Hearing Loss

All Sensorineural Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients
ClinicalTrials.gov ID: NCT02698787
Acronym / sponsor ID: FAST / CAM5621
Conditions: Sensorineural Hearing Loss
Keywords: cochlear implant, sensorineural hearing loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Study start: Dec 2015 (actual)
Primary completion: 19 Nov 2018 (actual)
Study completion: 19 Nov 2018 (actual)
First posted: 4 Mar 2016 (estimated)
Results: Posted 2 Feb 2021

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Device: Experimental sound coding strategy (FAST), Device: Commercially available ACE sound coding strategyAll patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.
Group 2	Experimental	Device: Experimental sound coding strategy (FAST), Device: Commercially available ACE sound coding strategyAll patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation.

Who may qualify

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

Key inclusion criteria (4 listed)

Medical and audiological candidate for a unilateral CI24RE, CI512 or CI532 series implant
Post-linguistically deafened
Native speaker of American English
Eighteen years of age or older

Key exclusion criteria (8 listed)

Previous or existing cochlear-implant recipient
Pre-linguistically deafened (onset of hearing loss at less than two years of age)
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
Diagnosis of retro-cochlear pathology
Diagnosis of auditory neuropathy

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
Experimental sound coding strategy (FAST)Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy	Device	Group 1, Group 2
Commercially available ACE sound coding strategyCommercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy	Device	Group 1, Group 2

Primary outcome

Change in Open Set Monosyllabic Word Recognition Score
Time frame: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)
Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct. The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct.
Change in Signal-to-Noise Ratio (SRT)
Time frame: Visit 5 (3 Months) and Visit 8 (6 months)
The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance. SRT measures are obtained using two types of background noise. One is "Speech-Shaped Noise" which is white noise or tones made to mimic speech. The other is "Four-Talker Noise" which is multiple talkers made to mimic background conversation.

Results and safety

Results posted to the registry on 2 Feb 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
Group 1: FAST First, Then ACE Sound Coding Strategy	6	6
Group 2: ACE First, Then FAST Sound Processng Strategy	5	5

Primary outcome: Change in Open Set Monosyllabic Word Recognition Score

Time frame: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months). Mean (Full Range). Unit: percentage of words correct

Measure	Group 1: FAST First, Then ACE Sound Processing Strategy n = 6	Group 2: ACE First, Then FAST Sound Processing Strategy n = 5
Visit 1 (Candidacy) - Implated Ear	5 (0 to 17)	11.8 (0 to 27)
Visit 1 (Candidacy) - Contralateral Ear	20.2 (1 to 55)	21.4 (2 to 38)
Visit 5 (3 Months) - FAST	45 (9 to 69)	–
Visit 5 (3 Month) - ACE	–	59.4 (39 to 85)
Visit 8 (6 Month) - ACE	49.5 (15 to 79)	–
Visit 8 (6 Month) - FAST	–	54 (27 to 76)

Population analysed: Group 1 were analysed at Visit 5 for FAST sound coding strategy and at Visit 8 for ACE sound coding strategy. Group 2 were analysed at Visit 5 for ACE sound coding strategy and at Visit 8 for FAST sound coding strategy.

Primary outcome: Change in Signal-to-Noise Ratio (SRT)

Time frame: Visit 5 (3 Months) and Visit 8 (6 months). Mean (Full Range). Unit: signal-to-noise ratio

Measure	Group 1: FAST First, Then ACE Sound Processing Strategy n = 6	Group 2: ACE First, Then FAST Sound Processing Strategy n = 5
Visit 5 - FAST (Speech-Shaped Noise)	16.3 (9.1 to 32.6)	–
Visit 5 - FAST (Four-Talker Noise)	16.3 (7.8 to 30.5)	–
Visit 5 - ACE(Speech-Shaped Noise)	–	11.2 (4.9 to 21.6)
Visit 5 - ACE (Four-Talker Noise)	–	10.1 (4.1 to 23.0)
Visit 8 - FAST (Speech-Shaped Noise)	–	13.1 (5.8 to 28.0)
Visit 8 - FAST (Four-Talker Noise)	–	12.4 (7 to 26)
Visit 8 - ACE(Speech-Shaped Noise)	9.9 (6.1 to 14.8)	–
Visit 8 - ACE (Four-Talker Noise)	9.1 (6.0 to 15.9)	–

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Sound Coding Strategy	1 of 11 (9.1%)	5 of 11 (45.5%)	0 of 11
FAST Sound Coding Strategy	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
ACE Sound Coding Strategy	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundDaneman , M., & Carpenter, P.A. (1980). Individual differences in working memory and reading. Journal of Verbal Learning andVerbal Behavior, 19, 450-466.
Background: PubMed 23651462Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. 2013 Jun;52(6):409-12. doi: 10.3109/14992027.2013.781278.
Background: PubMed 486816Bench J, Kowal A, Bamford J. The BKB (Bamford-Kowal-Bench) sentence lists for partially-hearing children. Br J Audiol. 1979 Aug;13(3):108-12. doi: 10.3109/03005367909078884.
Background: PubMed 14485785PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
BackgroundSmith, Z. M. (2010). Improved sensitivity to interaural time differences with the FAST coding strategy. Presented at the 11th International Conference on Cochlear Implants and Other Implantable Auditory Technologies, Stockholm, Sweden.

Related trials for Sensorineural Hearing Loss

Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
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An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Experimental sound coding strategy (FAST) and Commercially available ACE sound coding strategy in people with Sensorineural Hearing Loss, run by Cochlear at 1 site in United States.

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 8 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 2 Feb 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 United States. 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 2 Feb 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?

Change in Open Set Monosyllabic Word Recognition Score (time frame: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)). 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 NCT02698787, which also lists 5 linked publications.

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 2 Feb 2021; AzTrials last refreshed its copy on 28 Oct 2026.