Severe-to-profound Hearing LossNCT01824563
Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing
An observational study of Severe-to-profound Hearing Loss, run by Advanced Bionics AG at 1 site in Netherlands.
Trial summary
The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Severe-to-profound Hearing Loss
- What is being tested?
- Observational study
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Aug 2017
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals with severe-to-profound hearing loss
Who may be able to join
- 18 years of age or older
- Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education.
- Local language proficiency
- Bilateral, sensorineural hearing loss
Who cannot join
- Previous inner ear surgery or active middle ear pathology.
- Cochlear malformation or obstruction
- 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
- Concurrent participation in other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing.
The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.
- Conditions
- Severe-to-profound Hearing Loss
- Being tested
- Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| study population | Subjects will need to be standard CI patients acording to national implant criteria and the study criteria. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
CI aided word recognition scores in quiet and noise.
CI aided word recognition scores in quiet and noise.
Measured: 12 months post activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe-to-profound 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Frijns, Prof Dr, Principal investigator, LUMC - Department of ORL-HNS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824563
- Sponsor's protocol ID
- AB-RCA-01-2013
- Status last verified
- Jan 2018
- First submitted
- 22 Mar 2013
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing.
- ClinicalTrials.gov ID
- NCT01824563
- Acronym / sponsor ID
- AB-RCA-01-2013
- Conditions
- Severe-to-profound Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Advanced Bionics AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 5 Apr 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 goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | – | Other: Observational studySubjects will need to be standard CI patients acording to national implant criteria and the study criteria. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with severe-to-profound hearing loss
Key inclusion criteria (4 listed)
- 18 years of age or older
- Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education.
- Local language proficiency
- Bilateral, sensorineural hearing loss
Key exclusion criteria (6 listed)
- Previous inner ear surgery or active middle ear pathology.
- Cochlear malformation or obstruction
- 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 |
|---|---|---|
| Observational study | Other | study population |
Primary outcome
CI aided word recognition scores in quiet and noise.
Time frame: 12 months post activation
CI aided word recognition scores in quiet and noise.
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 9 Jan 2018.
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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.
Johan Frijns, Prof Dr principal investigator
LUMC - Department of ORL-HNS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe-to-profound Hearing Loss, run by Advanced Bionics AG at 1 site in Netherlands.
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 6 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 9 Jan 2018. 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 Netherlands. 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?
CI aided word recognition scores in quiet and noise. (time frame: 12 months post activation). 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 9 Jan 2018.