Hearing Loss, SensorineuralNCT03031678
Electric-Acoustic Stimulation Extended Follow-up Post Approval Study
A study testing Electric-Acoustic Stimulation (EAS) Cochlear Implant System in people with Hearing Loss, Sensorineural, run by Med-El Corporation at 7 sites in United States.
Trial summary
The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Electric-Acoustic Stimulation (EAS) Cochlear Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older at the time of implantation
- Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
- Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
- CNC word recognition score less than or equal to 60% in the ear to be implanted
- CNC word recognition score less than or equal to 60% in the contralateral ear
- English spoken as the primary language
Who cannot join
- Conductive, retrocochlear, or central auditory disorder
- Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
- Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
- Developmental delays or organic brain dysfunction
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
- Unwillingness or inability of the candidate to comply with all investigational requirements
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of North Carolina
Chapel Hill, North Carolina, 27517
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Kansas University Medical Center
Kansas City, Kansas, 66160
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Stanford Unversity
Palo Alto, California, 94303
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.
Read the detailed description
The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Electric-Acoustic Stimulation (EAS) Cochlear Implant System
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric-Acoustic Stimulation (EAS) Cochlear Implant SystemDevice
Also called EAS
Combination of a cochlear implant and a hearing aid
| Study group | Role | What they receive |
|---|---|---|
| Study procedures | Other | Not described Receives: Device: Electric-Acoustic Stimulation (EAS) Cochlear Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Words Correct As Assessed by CUNY Sentence Test.
Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.
Measured: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Secondary outcomes (3)
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.
The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer.
Measured: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Percentage of Words Correct as Assessed by CNC Words in Quiet.
Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation.
Measured: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.
The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects.
Measured: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031678
- Sponsor's protocol ID
- P000025/PAS001
- Status last verified
- Aug 2020
- First submitted
- 13 Jan 2017
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059.
PubMed 24328756
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
- ClinicalTrials.gov ID
- NCT03031678
- Acronym / sponsor ID
- P000025/PAS001
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Posted 10 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.
Detailed description
The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study procedures | Other | Device: Electric-Acoustic Stimulation (EAS) Cochlear Implant System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older at the time of implantation
- Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
- Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
- CNC word recognition score less than or equal to 60% in the ear to be implanted
- CNC word recognition score less than or equal to 60% in the contralateral ear
Key exclusion criteria (6 listed)
- Conductive, retrocochlear, or central auditory disorder
- Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
- Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
- Developmental delays or organic brain dysfunction
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
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 |
|---|---|---|
| Electric-Acoustic Stimulation (EAS) Cochlear Implant SystemAlso: EASCombination of a cochlear implant and a hearing aid | Device | Study procedures |
Primary outcome
Percentage of Words Correct As Assessed by CUNY Sentence Test.
Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation.
3 secondary outcomes
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.
Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Percentage of Words Correct as Assessed by CNC Words in Quiet.
Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.
Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24328756Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric-Acoustic Stimulation (EAS) Cochlear Implant System in people with Hearing Loss, Sensorineural, run by Med-El Corporation at 7 sites 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 6 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 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 10 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Words Correct As Assessed by CUNY Sentence Test. (time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031678, which also lists 1 linked publication.
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 10 Sep 2020.