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Middle East MED-EL Observatory Study

Middle East MED-EL Observatory Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03882229
Acronym
MEMOS
Enrollment
100
Registered
2019-03-20
Start date
2020-02-11
Completion date
2030-01-01
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Implants

Keywords

Registry, Observational Study

Brief 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. 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.

Interventions

DEVICEMED-EL CI systems

• Cochlear Implant (CI) and external audio processor

Sponsors

MED-EL Elektromedizinische Geräte GesmbH
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Subjects who are implanted or will be implanted with a MED-EL CI system. * Signed written informed consent for data collection for registry purposes.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Hearing threshold level5 yearsAudiometry testing (unaided)
Quality of hearing - adults5 yearsResults from the Hearing Implant Sound Quality Index (HISQUI 19)
Auditory development - children (CAP)5 yearsResults from the Categories of Auditory Performance (CAP)
Auditory development - children (SIR)5 yearsResults from the Speech Intelligibility Rating (SIR)
Auditory development - children (LEAQ)5 yearsResults from the LittlEARS Auditory Questionnaire (LEAQ)

Countries

Egypt, Saudi Arabia

Contacts

PRINCIPAL_INVESTIGATORAbdulrahman Ahmed Alsanosi, Prof.

King Abdullah Ear Specialist Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026