Hearing LossCROSNCT03243097
CROS Application in CI
A study testing Phase I - Standard Microphone Cros Input, Phase II - Automatic directional microphone Cros Input and Phase III - No Cros Input in people with Hearing Loss, run by University of Miami at 1 site in United States.
Trial summary
Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Phase I - Standard Microphone Cros Input, Phase II - Automatic directional microphone Cros Input and Phase III - No Cros Input
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 26 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
- Unilateral Advanced Bionics CI recipient
- ≥ 6 months CI-listening experience and/or better than 50%-word recognition on Consonant-Nucleus-Consonant (CNC) word testing
- English speaking
Who cannot join
- Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Department of Otolaryngology
Miami, Florida, 33136
About this study
Official title: Contralateral Routing of Signal in Unilateral Cochlear Implant Users
Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. For unilateral CI users, the deficits inherently associated with monaural listening remain despite the considerable benefits achieved through implantation. Providing bilateral input to monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral routing of signal (CROS) hearing aids, where the signal of interest is routed from the impaired (deaf) ear to the normal cochlea for processing is a promising alternative in unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology provides a less invasive alternative for patients who are unable or unwilling to undergo a second CI surgery and offers an innovative approach to resolving the auditory deficits associated with monaural listening. CROS technology has been used to treat traditional monaural listeners since 1965. When applied to unilateral CI users, this novel approach can overcome a key limitation of current treatment by restoring access to sound from the non-implanted ear and improving speech perception in noise.
- Conditions
- Hearing Loss
- Being tested
- Phase I - Standard Microphone Cros Input, Phase II - Automatic directional microphone Cros Input, Phase III - No Cros Input
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I - Standard Microphone Cros InputDevice
Subject will be fit with the research processor plus CROS microphone and wear for a 4 week period
Phase II - Automatic directional microphone Cros InputDevice
Automatic directional microphone technology will be activated in the research processor. Subjects will wear the CI+CROS configuration with directionality activated exclusively for 4-weeks.
Phase III - No Cros InputDevice
Subjects will return the research processor and CROS device and wear their own processor for a 2-week period
| Study group | Role | What they receive |
|---|---|---|
| Study Subjects | Experimental | All subjects enrolled in the study are required to complete Phase I before entering Phase II, and Phase II before entering Phase III. Receives: Device: Phase I - Standard Microphone Cros Input; Device: Phase II - Automatic directional microphone Cros Input; Device: Phase III - No Cros Input |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech perception in noise
Speech perception in noise will be evaluated with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.
Measured: 8 weeks
Secondary outcomes (1)
Subjective Benefit
Benefit of wireless CROS technology with the cochlear implant will be assessed using a customized questionnaire with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start24 Aug 2017
- Primary completion12 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hillary A Snapp, University of Miami
- Investigators
- Hillary Snapp, AuD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243097
- Sponsor's protocol ID
- 20170029
- Acronym
- CROS
- Status last verified
- Apr 2023
- First submitted
- 7 Jun 2017
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralateral Routing of Signal in Unilateral Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT03243097
- Acronym / sponsor ID
- CROS / 20170029
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 8 Aug 2017 (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.
Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. For unilateral CI users, the deficits inherently associated with monaural listening remain despite the considerable benefits achieved through implantation. Providing bilateral input to monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral routing of signal (CROS) hearing aids, where the signal of interest is routed from the impaired (deaf) ear to the normal cochlea for processing is a promising alternative in unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology provides a less invasive alternative for patients who are unable or unwilling to undergo a second CI surgery and offers an innovative approach to resolving the auditory deficits associated with monaural listening. CROS technology has been used to treat traditional monaural listeners since 1965. When applied to unilateral CI users, this novel approach can overcome a key limitation of current treatment by restoring access to sound from the non-implanted ear and improving speech perception in noise.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Subjects | Experimental | Device: Phase I - Standard Microphone Cros Input, Device: Phase II - Automatic directional microphone Cros Input, Device: Phase III - No Cros InputAll subjects enrolled in the study are required to complete Phase I before entering Phase II, and Phase II before entering Phase III. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral Advanced Bionics CI recipient
- ≥ 6 months CI-listening experience and/or better than 50%-word recognition on Consonant-Nucleus-Consonant (CNC) word testing
- English speaking
Key exclusion criteria (1 listed)
- Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study
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 |
|---|---|---|
| Phase I - Standard Microphone Cros InputSubject will be fit with the research processor plus CROS microphone and wear for a 4 week period | Device | Study Subjects |
| Phase II - Automatic directional microphone Cros InputAutomatic directional microphone technology will be activated in the research processor. Subjects will wear the CI+CROS configuration with directionality activated exclusively for 4-weeks. | Device | Study Subjects |
| Phase III - No Cros InputSubjects will return the research processor and CROS device and wear their own processor for a 2-week period | Device | Study Subjects |
Primary outcome
Speech perception in noise
Time frame: 8 weeks
Speech perception in noise will be evaluated with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.
1 secondary outcome
Subjective Benefit
Time frame: 8 weeks
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 27 Apr 2023.
- 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.
Hillary Snapp, AuD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase I - Standard Microphone Cros Input, Phase II - Automatic directional microphone Cros Input and Phase III - No Cros Input in people with Hearing Loss, run by University of Miami 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 3 inclusion and 1 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 27 Apr 2023. 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?
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?
Speech perception in noise (time frame: 8 weeks). 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 27 Apr 2023.