Hearing LossNCT01959152
Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
A study testing HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode in people with Hearing Loss and Deafness, run by Advanced Bionics at 3 sites in Canada.
Trial summary
The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Deafness, Hearing Disorders
- What is being tested?
- HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2013to Nov 2014
- 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
- No previous cochlear implant experience
- 18 years of age or older
- Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the ear to be implanted
- Aided monosyllabic word score of 10-50% in the ear to be implanted
- Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
- English language proficiency
- Willingness to participate in all scheduled procedures outlined in the protocol
Who cannot join
- Previous inner ear surgery
- Cochlear malformation or obstruction that would preclude full insertion of electrode array
- Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
- Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
- Evidence of central auditory lesion or compromised auditory nerve
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Dalhousie University, Department of Surgery, Division of Otolaryngology
Halifax, Nova Scotia, B3H 2Y9
The Ottawa Hospital, Parkdale Clinic, Audiology Department
Ottawa, Ontario, K1Y 4E9
Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery
Toronto, Ontario, M4N 3M5
About this study
The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.
- Being tested
- HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
- Keywords
- Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, HiRes Fidelity 120™, Electrical Stimulation
- Medical subject headings
- Hearing Loss, Deafness, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrodeDevice
| Study group | Role | What they receive |
|---|---|---|
| HiRes90K™ Advantage Cochlear Implant | Experimental | HiRes90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies. Receives: Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array
Unaided low-frequency acoustic hearing thresholds (under earphones) in the implanted ear one month after device activation will be compared to baseline (pre-implant) thresholds in the same ear for audiometric frequencies 125-1000Hz. Threshold changes from baseline will be calculated as:
- Complete preservation of hearing: threshold shift ≤ 15 dB
- Partial preservation of hearing: threshold shift ≥ 16 dB with measurable thresholds
- No preservation of hearing: no measurable thresholds at ≤ 80 dB HL
Measured: One month
Secondary outcomes (1)
Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array
Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionNov 2014
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959152
- Sponsor's protocol ID
- CR0513
- Status last verified
- Apr 2015
- First submitted
- 8 Oct 2013
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
- ClinicalTrials.gov ID
- NCT01959152
- Acronym / sponsor ID
- CR0513
- Keywords
- Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, HiRes Fidelity 120™
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Advanced BionicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- 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 purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HiRes90K™ Advantage Cochlear Implant | Experimental | Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrodeHiRes90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No previous cochlear implant experience
- 18 years of age or older
- Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the ear to be implanted
- Aided monosyllabic word score of 10-50% in the ear to be implanted
- Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
Key exclusion criteria (5 listed)
- Previous inner ear surgery
- Cochlear malformation or obstruction that would preclude full insertion of electrode array
- Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
- Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
- Evidence of central auditory lesion or compromised auditory nerve
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 |
|---|---|---|
| HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode | Device | HiRes90K™ Advantage Cochlear Implant |
Primary outcome
Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array
Time frame: One month
Unaided low-frequency acoustic hearing thresholds (under earphones) in the implanted ear one month after device activation will be compared to baseline (pre-implant) thresholds in the same ear for audiometric frequencies 125-1000Hz. Threshold changes from baseline will be calculated as: * Complete preservation of hearing: threshold shift ≤ 15 dB * Partial preservation of hearing: threshold shift ≥ 16 dB with measurable thresholds * No preservation of hearing: no measurable thresholds at ≤ 80 dB HL
1 secondary outcome
Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array
Time frame: One month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode in people with Hearing Loss and Deafness, run by Advanced Bionics at 3 sites 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early. Results are not available in the source record.
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?
Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array (time frame: One month). 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 21 May 2015.