Severe to Profound Hearing LossBELPSNCT07777562
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
An observational study of Severe to Profound Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Switzerland.
Trial summary
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized. The data extraction is performed as a one-time process. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe to Profound Hearing Loss
- What is being tested?
- Cochlear implantation
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 700 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes all patients registered in the sites local database who were implanted with an approved MED-EL cochlear implant at the investigational site since 01st January 1996. To be included for analysis data from the pre-operative assessment and from at least one post-operative assessment must be available.
Who may be able to join
- Implanted with a MED-EL cochlear implant
- First implantation at Inselspital Bern
- Implanted later than 31st December 1995
Who cannot join
- Lack of compliance with any inclusion criteria
- Patients implanted with either a custom-made device or with a study device prior CE-marking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
Bern, 3010
Martin Kompis, Prof. Dr. med. Dr. sc. techn., +41316323300, martin.kompis@insel.ch
Christoph Schmid, +41316323383, christoph.schmid@insel.ch
About this study
Official title: Bern Long-term Performance and Safety of MED-EL Cochlear Implants: a Retrospective Anonymized Analysis of Existing Data From the Local Clinical Database
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized. The data extraction is performed as a one-time process. Following the analysis of the extracted dataset, the study is considered complete.
The study does not foresee any active participation of patients or seeking for consent.
Read more
This retrospective anonymized database analysis is performed on all MED-EL cochlear implants registered in the local database of the Department of Otolaryngology, Head and Neck Surgery, Audiology, Inselspital, University of Bern.
The aim of this project is to generate evidence on the clinical effectiveness of cochlear implants based on long term real-world data gathered from clinical routine across a large and diverse population.
Assessed performance outcome measures include word test in quiet results, speech perception in noise results, and patient related outcome measures/questionnaires, as available. Safety assessment is based on data related to revision surgeries, explantations, reimplantations, and any other recorded device related complications. Imaging data (X-ray, CT, MRI) are not used in this study.
Read the detailed description
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized. The data extraction is performed as a one-time process. Following the analysis of the extracted dataset, the study is considered complete.
The study does not foresee any active participation of patients or seeking for consent.
This retrospective anonymized database analysis is performed on all MED-EL cochlear implants registered in the local database of the Department of Otolaryngology, Head and Neck Surgery, Audiology, Inselspital, University of Bern.
The aim of this project is to generate evidence on the clinical effectiveness of cochlear implants based on long term real-world data gathered from clinical routine across a large and diverse population.
Assessed performance outcome measures include word test in quiet results, speech perception in noise results, and patient related outcome measures/questionnaires, as available. Safety assessment is based on data related to revision surgeries, explantations, reimplantations, and any other recorded device related complications. Imaging data (X-ray, CT, MRI) are not used in this study.
- Conditions
- Severe to Profound Hearing Loss
- Being tested
- Cochlear implantation
- Keywords
- hearing loss, deafness, cochlear implant
- Medical subject headings
- Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantationDevice
Also called CI, Hearing implant
The cochlear implant (CI) is one of the most successful neural prostheses developed to date. It offers artificial hearing to individuals with profound sensorineural hearing loss and with insufficient benefit from conventional hearing aids. The first implants provided a limited sensation of sound. The benefit for users of these early systems was mostly a facilitation of lip-reading based communication rather than an understanding of speech. Considerable progress has been made since then. Today, cochlear implantation is the recommended treatment for subjects presenting with a permanent sensorineural hearing loss. Modern, multichannel implant systems feature complex speech processing strategies, high stimulation rates and multiple sites of stimulation in the cochlea. Equipped with such a state-of-the-art system, the majority of recipients today can communicate orally without visual cues and can even use the telephone.
| Study group | Role | What they receive |
|---|---|---|
| MED-EL cochlear implant recipients | The cohort includes all patients registered in the sites local database who were implanted with an approved MED-EL cochlear implant at the investigational site since 01st January 1996. To be included for analysis data from the pre-operative assessment and from at least one post-operative assessment must be available. Receives: Device: Cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word Recognition Score in % correct over time
The primary objective of this retrospective observational study is to evaluate speech performance in quiet over time of MED-EL cochlear implant users, measured as the percentage of words recognized correctly.
Measured: Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
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
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777562
- Sponsor's protocol ID
- MED-EL_CRD_2026_02
- Acronym
- BELPS
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bern Long-term Performance and Safety of MED-EL Cochlear Implants: a Retrospective Anonymized Analysis of Existing Data From the Local Clinical Database
- ClinicalTrials.gov ID
- NCT07777562
- Acronym / sponsor ID
- BELPS / MED-EL_CRD_2026_02
- Conditions
- Severe to Profound Hearing Loss
- Keywords
- hearing loss, deafness, cochlear implant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Aug 2026 (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.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized. The data extraction is performed as a one-time process. Following the analysis of the extracted dataset, the study is considered complete.
The study does not foresee any active participation of patients or seeking for consent.
This retrospective anonymized database analysis is performed on all MED-EL cochlear implants registered in the local database of the Department of Otolaryngology, Head and Neck Surgery, Audiology, Inselspital, University of Bern.
The aim of this project is to generate evidence on the clinical effectiveness of cochlear implants based on long term real-world data gathered from clinical routine across a large and diverse population.
Assessed performance outcome measures include word test in quiet results, speech perception in noise results, and patient related outcome measures/questionnaires, as available. Safety assessment is based on data related to revision surgeries, explantations, reimplantations, and any other recorded device related complications. Imaging data (X-ray, CT, MRI) are not used in this study.
Detailed description
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized. The data extraction is performed as a one-time process. Following the analysis of the extracted dataset, the study is considered complete.
The study does not foresee any active participation of patients or seeking for consent.
This retrospective anonymized database analysis is performed on all MED-EL cochlear implants registered in the local database of the Department of Otolaryngology, Head and Neck Surgery, Audiology, Inselspital, University of Bern.
The aim of this project is to generate evidence on the clinical effectiveness of cochlear implants based on long term real-world data gathered from clinical routine across a large and diverse population.
Assessed performance outcome measures include word test in quiet results, speech perception in noise results, and patient related outcome measures/questionnaires, as available. Safety assessment is based on data related to revision surgeries, explantations, reimplantations, and any other recorded device related complications. Imaging data (X-ray, CT, MRI) are not used in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MED-EL cochlear implant recipients | – | Device: Cochlear implantationThe cohort includes all patients registered in the sites local database who were implanted with an approved MED-EL cochlear implant at the investigational site since 01st January 1996. To be included for analysis data from the pre-operative assessment and from at least one post-operative assessment must be available. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes all patients registered in the sites local database who were implanted with an approved MED-EL cochlear implant at the investigational site since 01st January 1996. To be included for analysis data from the pre-operative assessment and from at least one post-operative assessment must be available.
Key inclusion criteria (3 listed)
- Implanted with a MED-EL cochlear implant
- First implantation at Inselspital Bern
- Implanted later than 31st December 1995
Key exclusion criteria (2 listed)
- Lack of compliance with any inclusion criteria
- Patients implanted with either a custom-made device or with a study device prior CE-marking
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 |
|---|---|---|
| Cochlear implantationAlso: CI, Hearing implantThe cochlear implant (CI) is one of the most successful neural prostheses developed to date. It offers artificial hearing to individuals with profound sensorineural hearing loss and with insufficient benefit from conventional hearing aids. The first implants provided a limited sensation of sound. The benefit for users of these early systems was mostly a facilitation of lip-reading based communication rather than an understanding of speech. Considerable progress has been made since then. Today, cochlear implantation is the recommended treatment for subjects presenting with a permanent sensorineural hearing loss. Modern, multichannel implant systems feature complex speech processing strategies, high stimulation rates and multiple sites of stimulation in the cochlea. Equipped with such a state-of-the-art system, the majority of recipients today can communicate orally without visual cues and can even use the telephone. | Device | MED-EL cochlear implant recipients |
Primary outcome
Word Recognition Score in % correct over time
Time frame: Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.
The primary objective of this retrospective observational study is to evaluate speech performance in quiet over time of MED-EL cochlear implant users, measured as the percentage of words recognized correctly.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Severe to Profound Hearing Loss
RecruitingObservational study
Language Development in Children With Cochlear Implants and Speech-language Therapy Interventions
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Active, not recruiting
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
Sensori-Neural Deafness, Sensorineural Hearing Loss
Not yet recruitingObservational study
Correlations Between Subjective and Objective Responses to Cochlear Implant Stimulation
Severe to Profound Sensorineural Hearing Loss
Recruiting
Hearing and Structure Preservation Via ECochG
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Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
Severe to Profound Hearing Loss
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.
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 MED-EL Elektromedizinische Geräte GmbH at 1 site in Switzerland.
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 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: opening soon, as of the sponsor's last update on 9 Sep 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Eisendle (+43577881694, martin.eisendle@medel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word Recognition Score in % correct over time (time frame: Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.). 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 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.