Cochlear ImplantsMEMOSNCT03882229
Middle East MED-EL Observatory Study
An observational study of Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 3 sites in 2 countries.
Trial summary
In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness. Longitudinal comparisons of data collected in different clinics is challenging due to the heterogeneity in measures and procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cochlear Implants
- What is being tested?
- MED-EL CI systems
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Feb 2020to Jan 2030
- How long will I take part?
- 5 Years
- 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: Subjects of any age and gender who are implanted or will be implanted with a MED-EL CI system.
Who may be able to join
- Subjects who are implanted or will be implanted with a MED-EL CI system.
- Signed written informed consent for data collection for registry purposes.
Who cannot join
- Lack of compliance with any inclusion criteria.
- Subjects not receiving a MED-EL CI system due to medical or personal reasons after having consented.
- Anything that, in the opinion of the Investigator would place the subject at increased risk or preclude the subject's full compliance with or completion of the registry procedures.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Saud Medical City
Riyāḑ, 12746
Fahad Altamimi, Dr., +966505146372, f.altamimi@ksmc.med.sa
Yassin Abdelsamad, Dr., yassin.samad@medel.com
- Recruiting
King Abdullah Ear Specialist Center (KAESC)
Riyadh, 11411
Yassin Abdelsamad, 00966558842365, Yassin.Samad@medel.com
Egypt1 site, 1 recruiting
- Recruiting
Hearing and Speech Institute
Cairo
Ahmed Mustafa, Prof, 01001676429, am.mustafa@windowslive.com
Moataz Abdel Baky, +201032266884, moataz.baky@medel.com
About this study
In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness. Longitudinal comparisons of data collected in different clinics is challenging due to the heterogeneity in measures and procedure.
This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as anonymized data sets, derived from original clinical records on appropriately informed subjects. Each subject will be treated as per clinical routine.
The Registry will be implemented through a secure, cloud-based, platform that enables collection of anonymized data at consistent time intervals, thus enabling the comparison of repeated measures over time.
- Conditions
- Cochlear Implants
- Being tested
- MED-EL CI systems
- Keywords
- Registry, Observational Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED-EL CI systemsDevice
- Cochlear Implant (CI) and external audio processor
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing threshold level
Audiometry testing (unaided)
Measured: 5 years
Quality of hearing - adults
Results from the Hearing Implant Sound Quality Index (HISQUI 19)
Measured: 5 years
Auditory development - children (CAP)
Results from the Categories of Auditory Performance (CAP)
Measured: 5 years
Auditory development - children (SIR)
Results from the Speech Intelligibility Rating (SIR)
Measured: 5 years
Auditory development - children (LEAQ)
Results from the LittlEARS Auditory Questionnaire (LEAQ)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start11 Feb 2020
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies 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
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdulrahman Ahmed Alsanosi, Prof., Principal investigator, King Abdullah Ear Specialist Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882229
- Sponsor's protocol ID
- MED-EL_CRD_2018_01
- Acronym
- MEMOS
- Status last verified
- Sep 2026
- First submitted
- 1 Mar 2019
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle East MED-EL Observatory Study
- ClinicalTrials.gov ID
- NCT03882229
- Acronym / sponsor ID
- MEMOS / MED-EL_CRD_2018_01
- Conditions
- Cochlear Implants
- Keywords
- Registry, Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 20 Mar 2019 (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.
In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness. Longitudinal comparisons of data collected in different clinics is challenging due to the heterogeneity in measures and procedure.
This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as anonymized data sets, derived from original clinical records on appropriately informed subjects. Each subject will be treated as per clinical routine.
The Registry will be implemented through a secure, cloud-based, platform that enables collection of anonymized data at consistent time intervals, thus enabling the comparison of repeated measures over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects of any age and gender who are implanted or will be implanted with a MED-EL CI system.
Key inclusion criteria (2 listed)
- Subjects who are implanted or will be implanted with a MED-EL CI system.
- Signed written informed consent for data collection for registry purposes.
Key exclusion criteria (3 listed)
- Lack of compliance with any inclusion criteria.
- Subjects not receiving a MED-EL CI system due to medical or personal reasons after having consented.
- Anything that, in the opinion of the Investigator would place the subject at increased risk or preclude the subject's full compliance with or completion of the registry procedures.
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 |
|---|---|---|
| MED-EL CI systems• Cochlear Implant (CI) and external audio processor | Device | – |
Primary outcome
Hearing threshold level
Time frame: 5 years
Audiometry testing (unaided)
Quality of hearing - adults
Time frame: 5 years
Results from the Hearing Implant Sound Quality Index (HISQUI 19)
Auditory development - children (CAP)
Time frame: 5 years
Results from the Categories of Auditory Performance (CAP)
Auditory development - children (SIR)
Time frame: 5 years
Results from the Speech Intelligibility Rating (SIR)
Auditory development - children (LEAQ)
Time frame: 5 years
Results from the LittlEARS Auditory Questionnaire (LEAQ)
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
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Mi2000 TICI Follow-up
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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.
Abdulrahman Ahmed Alsanosi, Prof. principal investigator
King Abdullah Ear Specialist Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 3 sites in 2 countries.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 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 3 sites in Saudi Arabia, Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing threshold level (time frame: 5 years). The study lists 5 primary outcomes in all. 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 16 Sep 2026.