Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.

NCT07697911 | Not Yet Recruiting

• 1 other identifier: MED-EL_CRD_2025_01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. However, there is only few evidence from large long-term observational studies available to gain knowledge on clinical effectiveness of cochlear implants. With continued pressure on healthcare system budgets, there is an increasing demand for evidence-based research that demonstrates an intervention is effective in the real-world environment across large and diverse populations. Currently, there is a paucity of data concerning the long-term outcomes of subjects implanted with a SONATA 2 cochlear implant from representative samples of the population. This retrospective study aims at analyzing SONATA 2 cochlear implant data from clinical routine.

Conditions

Cochlear Implant; SONATA 2; Cochlear Implantation

Keywords

retrospective data collection

Outcome Measures

Primary Outcomes (1)

• Bisyllables recognition score in quiet

  pre-operative to 5 years post-operative

Secondary Outcomes (10)

• Bisyllables recognition score in noise

  pre-operative to 5 years post-operative

• Wearing time

  up to 5 years post-operative

• Hardware and device parameters

  up to 5 years post-operative

• Demographic information

  pre-operative

• Complications related to the device or procedure

  up to 5 years post-operative

Interventions

Transfer of data of SONATA 2 cochlear implant recipients OTHER

Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this retrospective observational study, the inclusion and exclusion criteria encompass all individuals with a SONATA 2 cochlear implant at the study centers. By including all individuals with a SONATA 2 cochlear implant from the study centers, the investigation population is representative of the target population. The investigation population is representative of "real-world" users of SONATA 2 cochlear implant.

You may qualify if:

• At least one MED-EL SONATA 2 cochlear implant with a compatible MED-EL audio processor

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (2)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Central Study Contacts

Jasmine Rinnofner

CONTACT

+43577881694; jasmine.rinnofner@medel.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)