Cochlear ImplantNCT04222296
Bimodal, CROS and Severe Profound Hearing Loss Study
A study testing Fitting strategy of cohlear implant of hearing aid in people with Cochlear Implant and Severe-Profound Hearing Loss, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implant, Severe-Profound Hearing Loss, Hearing Loss, Bilateral
- What is being tested?
- Fitting strategy of cohlear implant of hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Sep 2018to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Consistent unilateral user of an Advanced Bionics cochlear implant and a contralateral hearing aid for at least 6 months, ideally 12 months, and Bilateral severe to profound hearing loss (meeting NICE criteria for implantation-2009). (group 1)
- Consistent unilateral user of an Advanced Bionics cochlear implant for at least 6 months and ideally 12 months, with no useful contralateral hearing (group 2)
- Consistent user of bilateral hearing aids for at least six months (group 3) and bilateral severe profound hearing loss (80dB or worse at 2000 and 4000 Hz with speech discrimination of at least 50% IHR sentences live voice at 60dBA)
- First language English
- Post-lingual onset of severe to profound hearing loss
- No other handicaps that would interfere with participation in the study in the opinion of the Principle Investigator
Who cannot join
- Unstable cochlear implant or hearing aid fitting
- Using medication in an intermittent manner that might influence hearing levels
- Cognitive or psychological challenges that might lead to variations in attention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Outcomes With Hearing Aid Parameters Designed for Adults With Severe-profound Hearing Loss and Unilateral Cochlear Implants in Bimodal (Cochlear Implant and Contralateral Hearing Instrument), CROS (Contralateral Routing of Signals) and Bilateral Amplification Strategies
The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids.
This will enable a comparison of standard fitting protocols against the new rationale using the same devices. Devices used for patients in all 3 groups are now available in standard of care, and can be kept afterwards should the patients wish.
Read the detailed description
The study will involve three groups of 20 patients per group. This first is experienced adult bimodal users of the AB system who have usable contralateral residual hearing. A clinical baseline and three research conditions will be evaluated.
The Naida CI Link HA (Link) will be fitted, tested and then optimised using a special bimodal fitting formula. Subjects will be allowed three months to acclimatize and will then be retested. The second research condition will evaluate the fully integrated bimodal system, where the microphone signals from CI and HA are shared and a bilateral beamformer is formed. A third intervention will involve modifying the CI settings to minimize the mis-match between frequencies delivered via the CI.
A second group with no aidable hearing on their non-implanted ear will also be studied. A contralateral routing of signal (CROS) device will send sounds on the non-implanted side. Tests will be made with and without CROS, as well as with directional microphone settings.
Finally as a control group, bilateral HA users will be tested with the similar HA fitting as used for the bimodal group.
This will enable a comparison of standard fitting protocols against the new rationale using the same devices.
- Conditions
- Cochlear Implant, Severe-Profound Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Being tested
- Fitting strategy of cohlear implant of hearing aid
- Medical subject headings
- Hearing Loss, Bilateral, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitting strategy of cohlear implant of hearing aidDevice
To determine whether new hardware and fitting strategy provides better sound quality or ease of use than generic hardware and fitting methods
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant and Hearing Aid | Other | Comparing performance of conventional hearing aid fitting to Phonak's Bimodal Fitting formula using the Phonak Naida Link hearing aid. All patients are tested in a bimodal (hearing aid plus cochlear implant) setup. Initial tests are completed with the Advanced Bionics Naida Q70 or Q90 sound processor and the patient's own hearing aid. In this arm, a patient's own hearing aid is replaced with the Phonak Naida Link hearing aid to test if there is a benefit. Receives: Device: Fitting strategy of cohlear implant of hearing aid |
| Cochlear Implant alone | Other | To determine if the addition of a contralateral routing of signal (CROS) microphone on the un-implanted ear improves performance. Baseline tests are completed with Advanced Bionics Naida Q70 or Q90 sound processors. Patients are then given the Phonak Naida Link CROS aid to test if there is a benefit. Receives: Device: Fitting strategy of cohlear implant of hearing aid |
| Hearing Aid and Hearing Aid | Other | Comparing performance of conventional hearing aid fitting to a modified signal processing strategy more aligned with how a cochlear implant manages sound. All patients are tested initially with their own hearing aids to obtain a baseline measurement. Patients are then fitted with a modified Phonak hearing aid to determine if performance improves. Receives: Device: Fitting strategy of cohlear implant of hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound Processing parameters
ASSE score
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start4 Sep 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Bionics AG
- Responsible party
- Principal investigator, James Tysome, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- James R Tysome, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222296
- Sponsor's protocol ID
- 18/EE/0160
- Status last verified
- Jun 2021
- First submitted
- 23 Jan 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Outcomes With Hearing Aid Parameters Designed for Adults With Severe-profound Hearing Loss and Unilateral Cochlear Implants in Bimodal (Cochlear Implant and Contralateral Hearing Instrument), CROS (Contralateral Routing of Signals) and Bilateral Amplification Strategies
- ClinicalTrials.gov ID
- NCT04222296
- Acronym / sponsor ID
- 18/EE/0160
- Conditions
- Cochlear Implant, Severe-Profound Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Advanced Bionics AG
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids.
This will enable a comparison of standard fitting protocols against the new rationale using the same devices. Devices used for patients in all 3 groups are now available in standard of care, and can be kept afterwards should the patients wish.
Detailed description
The study will involve three groups of 20 patients per group. This first is experienced adult bimodal users of the AB system who have usable contralateral residual hearing. A clinical baseline and three research conditions will be evaluated.
The Naida CI Link HA (Link) will be fitted, tested and then optimised using a special bimodal fitting formula. Subjects will be allowed three months to acclimatize and will then be retested. The second research condition will evaluate the fully integrated bimodal system, where the microphone signals from CI and HA are shared and a bilateral beamformer is formed. A third intervention will involve modifying the CI settings to minimize the mis-match between frequencies delivered via the CI.
A second group with no aidable hearing on their non-implanted ear will also be studied. A contralateral routing of signal (CROS) device will send sounds on the non-implanted side. Tests will be made with and without CROS, as well as with directional microphone settings.
Finally as a control group, bilateral HA users will be tested with the similar HA fitting as used for the bimodal group.
This will enable a comparison of standard fitting protocols against the new rationale using the same devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant and Hearing Aid | Other | Device: Fitting strategy of cohlear implant of hearing aidComparing performance of conventional hearing aid fitting to Phonak's Bimodal Fitting formula using the Phonak Naida Link hearing aid. All patients are tested in a bimodal (hearing aid plus cochlear implant) setup. Initial tests are completed with the Advanced Bionics Naida Q70 or Q90 sound processor and the patient's own hearing aid. In this arm, a patient's own hearing aid is replaced with the Phonak Naida Link hearing aid to test if there is a benefit. |
| Cochlear Implant alone | Other | Device: Fitting strategy of cohlear implant of hearing aidTo determine if the addition of a contralateral routing of signal (CROS) microphone on the un-implanted ear improves performance. Baseline tests are completed with Advanced Bionics Naida Q70 or Q90 sound processors. Patients are then given the Phonak Naida Link CROS aid to test if there is a benefit. |
| Hearing Aid and Hearing Aid | Other | Device: Fitting strategy of cohlear implant of hearing aidComparing performance of conventional hearing aid fitting to a modified signal processing strategy more aligned with how a cochlear implant manages sound. All patients are tested initially with their own hearing aids to obtain a baseline measurement. Patients are then fitted with a modified Phonak hearing aid to determine if performance improves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Consistent unilateral user of an Advanced Bionics cochlear implant and a contralateral hearing aid for at least 6 months, ideally 12 months, and Bilateral severe to profound hearing loss (meeting NICE criteria for implantation-2009). (group 1)
- Consistent unilateral user of an Advanced Bionics cochlear implant for at least 6 months and ideally 12 months, with no useful contralateral hearing (group 2)
- Consistent user of bilateral hearing aids for at least six months (group 3) and bilateral severe profound hearing loss (80dB or worse at 2000 and 4000 Hz with speech discrimination of at least 50% IHR sentences live voice at 60dBA)
Key exclusion criteria (3 listed)
- Unstable cochlear implant or hearing aid fitting
- Using medication in an intermittent manner that might influence hearing levels
- Cognitive or psychological challenges that might lead to variations in attention
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 |
|---|---|---|
| Fitting strategy of cohlear implant of hearing aidTo determine whether new hardware and fitting strategy provides better sound quality or ease of use than generic hardware and fitting methods | Device | Cochlear Implant alone, Cochlear Implant and Hearing Aid, Hearing Aid and Hearing Aid |
Primary outcome
Sound Processing parameters
Time frame: 24 months
ASSE score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Cochlear Implant
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
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Mi2000 TICI Follow-up
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Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative 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
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.
James R Tysome principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitting strategy of cohlear implant of hearing aid in people with Cochlear Implant and Severe-Profound Hearing Loss, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 8 inclusion and 3 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 Jul 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sound Processing parameters (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2021.