MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

Hearing Loss Clinical Trial

— MEHS  

Official title:

MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668338
• Other study ID #: MED-EL_CRD_2015_06
• Status: Recruiting
• Start date: June 26, 2017
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: Jasmine Rinnofner
• Phone: +43 57 788 1694
• Email: jasmine.rinnofner[@]medel.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as fully anonymized data sets, derived from original clinical records on appropriately informed subjects.

This is a patient-outcomes Registry for subjects of any age who are provided in routine clinical practice with one or more MED-EL hearing devices. The Registry aims to collect data for hypothesis generation on subject device use, auditory performance, quality of life and health-related utilities, across different types of implantable and non-implantable hearing devices from MED-EL company. Subjects will be evaluated with a set of standardized tests and questionnaires prior to implantation or prior to initial device activation (baseline) and at follow-up intervals according to the clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• For children and adults receiving an implant: Subjects submitted or planned to be submitted to unilateral or bilateral implantation, using simultaneous or sequential procedures.

• For children and adults receiving a non-implantable device: Subjects submitted or planned to be submitted to unilateral or bilateral treatment with a non-implantable device from MED-EL.

• Unilateral, bilateral or bimodal users (children and adults) of cochlear implants (CIs), electric-acoustic devices, bone conduction implants, middle ear implants or any other implantable or non-implantable hearing solution from MED-EL.

• Signed written informed consent for data collection for Registry purposes.

Exclusion Criteria:

• Lack of compliance with any inclusion criteria.

• 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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Implantable or non-implantable MED-EL hearing solution
Receipt of an implantable or non-implantable MED-EL hearing solution

Locations

Country	Name	City	State
Germany	Katholisches Klinikum Bochum	Bochum
Germany	Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde	Dresden
Germany	Universitätsklinikum der Goethe-Universität	Frankfurt
Germany	Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg	Heidelberg
Germany	Klinikum der Universität München Campus Großhadern	München
Germany	Evangelisches Krankenhaus Oldenburg	Oldenburg
Germany	Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"	Rostock
Germany	Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Demographics		5 years
Primary	Hearing Threshold level	Audiometry testing (unaided)	5 years
Primary	Speech test	Results from speech tests	5 years
Primary	HISQUI (Hearing Implant Sound Quality Index)	Results from the HISQUI questionnaire	5 years
Primary	APHAB (Abbreviated Profile of Hearing Aid Benefit)	Results from the APHAB questionnaire	5 years
Primary	ASC (Auditory Skills Checklist)	Results from the ASC questionnaire	5 years
Primary	APSQ (Audio Processor Satisfaction Questionnaire)	Results from the APSQ questionnaire	5 years
Primary	LEAQ (LittlEars Auditory Questionnaire)	Results from the LEAQ questionnaire	5 years