Cochlear ImplantNCT04155138
Recipients With Limited Bimodal Benefit: HA or CROS
A study testing Naida Hearing Aid and Naida Contralateral Routing of Sound Device in people with Cochlear Implant and Hearing Disability, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant, Hearing Disability, Hearing Disorders and Deafness
- What is being tested?
- Naida Hearing Aid and Naida Contralateral Routing of Sound Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2019to 20 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years of age)
- Unilaterally implanted with an Advanced Bionics implant (CII or later)
- At least six months of CI use
- Limited bimodal benefit as perceived by the recipient and/or the clinician
- Participants may or may not currently be using a hearing aid in the unimplanted ear.
- Open set performance with current device configuration:
Show all 12Show fewer
- ≥40% AzBio sentence score in quiet (S0) and? (i.e. do both these apply)
- If currently bimodal:
- Hearing aid ear only CNC score <50%
- AzBio Scores bimodal benefit <15% increase in score compared to CI only?
- Unaided audiometric threshold of ≤100 dBHL up to 500 Hz
- Ability and willingness to participate in multiple sets of open speech testing (and ongoing evaluation of HA and CROS benefit)
Who cannot join
- Patients who are not proficient in English as the AzBio testing is available in English only.
- Patients with agenesis of the contralateral ear
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Ottawa Hospital
Ottawa, ON - Ontario, K1H 8L6
Debora L Hogan, MScN, 6137378899 ext. 72968, sisterssejour@hotmail.com
David Schramm, MD, 6137378899 ext. 72968, dschramm@toh.ca
About this study
The rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing.
Read the detailed description
It is well accepted that bilateral input can significantly improve speech understanding in noise for patients with cochlear implants. For cochlear implant (CI) recipients who have a CI on only one side, two sided input can be provided with simultaneous use of a hearing aid (HA) or a CROS device on the opposite side. The decision about which device to use depends on the level of residual hearing a recipient has in non CI-implanted ear, and more specifically what level of useable residual hearing s/he has. Access to useable low frequency hearing can not only improve speech understanding in noise, it can also improve sound quality, pitch perception and music perception.
Clinicians can reasonably predict that a recipient with hearing thresholds better than 60 dB HL at low frequencies (below 750 Hz) would benefit from amplification. For recipients with no measurable acoustic hearing in the contralateral ear, CROS would be a reasonable option, especially if bilateral implantation is not feasible or desired. However, it is more difficult to predict the appropriate device in individuals who have some measurable acoustic hearing but may be receiving limited benefit from it. This can be especially challenging because audiometric thresholds are not a reliable predictor of bimodal benefit. Additionally, acoustic hearing can provide subjective benefits which could hold different intrinsic value or significance for different individuals depending on their life style and listening needs.
- Being tested
- Naida Hearing Aid, Naida Contralateral Routing of Sound Device
- Keywords
- cochlear implant, hearing aid, cros device, bimodal
- Medical subject headings
- Hearing Disorders, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naida Hearing AidDevice
Also called HA
hearing aid
Naida Contralateral Routing of Sound DeviceDevice
Also called CROS
This is a device that routes sound to the non-cochlear implanted ear.
| Study group | Role | What they receive |
|---|---|---|
| Naida Hearing Aid | Other | Adults (> 18 years of age)
* Unilaterally implanted with an Advanced Bionics implant (CII or later)
* At least six months of CI use experience
* Limited bimodal benefit as perceived by the recipient and/or the clinician
* Participants may or may not currently be using a hearing aid in the unimplanted ear.
* Open set performance with current device configuration:
* ≥40% AzBio sentence score in quiet (S0)
* If currently bimodal:
* Hearing aid ear only CNC score <50%
* AzBio Scores bimodal benefit <15%
* Unaided audiometric threshold of ≤100 dBHL up to 500 Hz
* Ability and willingness to participate in multiple sets of open speech testing (and chronically evaluate HA and CROS benefit) Receives: Device: Naida Hearing Aid; Device: Naida Contralateral Routing of Sound Device |
| Naida CROS Device | Other | The same cohort will cross over to each arm. Receives: Device: Naida Hearing Aid; Device: Naida Contralateral Routing of Sound Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of speech by way of audiogram and AzBio word testing.
Change in perception of speech by way of audiogram (hearing threshold across dB and frequencies) and AzBio word testing (% accuracy).
Measured: At Baseline, Week 6 and Week 12
7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS
Change in 7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS. 1 (very dissatisfied) to 7 (very satisfied)
Measured: At Baseline, Week 6 and Week 12
Participant narrative illuminating subjective feedback of experience using HA or CROS
Evolution of narrative interview themes illuminating subjective feedback of experience using HA or CROS
Measured: At Baseline, Week 6 and Week 12
Secondary outcomes (1)
Demographics
Age, Gender, Hearing History
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion20 Mar 2021 (estimated)
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.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Naida Hearing Aid Naida CROS Device
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Bionics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155138
- Sponsor's protocol ID
- CRRF 842
- Status last verified
- Nov 2019
- First submitted
- 18 Oct 2018
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recipients With Limited Bimodal Benefit: HA or CROS
- ClinicalTrials.gov ID
- NCT04155138
- Acronym / sponsor ID
- CRRF 842
- Keywords
- cochlear implant, hearing aid, cros device, bimodal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Advanced Bionics
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 20 Mar 2021 (estimated)
- First posted
- 7 Nov 2019 (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 rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing.
Detailed description
It is well accepted that bilateral input can significantly improve speech understanding in noise for patients with cochlear implants. For cochlear implant (CI) recipients who have a CI on only one side, two sided input can be provided with simultaneous use of a hearing aid (HA) or a CROS device on the opposite side. The decision about which device to use depends on the level of residual hearing a recipient has in non CI-implanted ear, and more specifically what level of useable residual hearing s/he has. Access to useable low frequency hearing can not only improve speech understanding in noise, it can also improve sound quality, pitch perception and music perception.
Clinicians can reasonably predict that a recipient with hearing thresholds better than 60 dB HL at low frequencies (below 750 Hz) would benefit from amplification. For recipients with no measurable acoustic hearing in the contralateral ear, CROS would be a reasonable option, especially if bilateral implantation is not feasible or desired. However, it is more difficult to predict the appropriate device in individuals who have some measurable acoustic hearing but may be receiving limited benefit from it. This can be especially challenging because audiometric thresholds are not a reliable predictor of bimodal benefit. Additionally, acoustic hearing can provide subjective benefits which could hold different intrinsic value or significance for different individuals depending on their life style and listening needs.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Naida Hearing Aid Naida CROS Device
| Arm | Type | Receives |
|---|---|---|
| Naida Hearing Aid | Other | Device: Naida Hearing Aid, Device: Naida Contralateral Routing of Sound DeviceAdults (> 18 years of age) * Unilaterally implanted with an Advanced Bionics implant (CII or later) * At least six months of CI use experience * Limited bimodal benefit as perceived by the recipient and/or the clinician * Participants may or may not currently be using a hearing aid in the unimplanted ear. * Open set performance with current device configuration: * ≥40% AzBio sentence score in quiet (S0) * If currently bimodal: * Hearing aid ear only CNC score <50% * AzBio Scores bimodal benefit <15% * Unaided audiometric threshold of ≤100 dBHL up to 500 Hz * Ability and willingness to participate in multiple sets of open speech testing (and chronically evaluate HA and CROS benefit) |
| Naida CROS Device | Other | Device: Naida Hearing Aid, Device: Naida Contralateral Routing of Sound DeviceThe same cohort will cross over to each arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults (> 18 years of age)
- Unilaterally implanted with an Advanced Bionics implant (CII or later)
- At least six months of CI use
- Limited bimodal benefit as perceived by the recipient and/or the clinician
- Participants may or may not currently be using a hearing aid in the unimplanted ear.
Key exclusion criteria (2 listed)
- Patients who are not proficient in English as the AzBio testing is available in English only.
- Patients with agenesis of the contralateral ear
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 |
|---|---|---|
| Naida Hearing AidAlso: HAhearing aid | Device | Naida CROS Device, Naida Hearing Aid |
| Naida Contralateral Routing of Sound DeviceAlso: CROSThis is a device that routes sound to the non-cochlear implanted ear. | Device | Naida CROS Device, Naida Hearing Aid |
Primary outcome
Perception of speech by way of audiogram and AzBio word testing.
Time frame: At Baseline, Week 6 and Week 12
Change in perception of speech by way of audiogram (hearing threshold across dB and frequencies) and AzBio word testing (% accuracy).
7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS
Time frame: At Baseline, Week 6 and Week 12
Change in 7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS. 1 (very dissatisfied) to 7 (very satisfied)
Participant narrative illuminating subjective feedback of experience using HA or CROS
Time frame: At Baseline, Week 6 and Week 12
Evolution of narrative interview themes illuminating subjective feedback of experience using HA or CROS
1 secondary outcome
Demographics
Time frame: At Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naida Hearing Aid and Naida Contralateral Routing of Sound Device in people with Cochlear Implant and Hearing Disability, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 12 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Nov 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debora L Hogan, M.Sc.N. (6137378899 ext. 72968, dhogan@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of speech by way of audiogram and AzBio word testing. (time frame: At Baseline, Week 6 and Week 12). The study lists 3 primary outcomes in all. 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 7 Nov 2019.