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

Longitudinal Outcomes of SONATA 2 Cochlear Implant Recipients: a Retrospective Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cochlear Implant; Cochlear Implantation; SONATA 2
• Intervention / Treatment: Other: Transfer of data of SONATA 2 cochlear implant recipients

Detailed Description

Data from SONATA 2 CI recipients will be transferred to predefined fields in an electronic data capture system (CASTOR EDC) by the investigators. The data transfer starts after the approval of the Ethics Committees (EC). Data will be included for all subjects who meet the inclusion/exclusion criteria

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jasmine Rinnofner; Phone Number: +43577881694; Email: jasmine.rinnofner@medel.com

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
    • Contact: Luis Lassaletta Atienza, Dr.; Phone Number: +34 91 207 1651; Email: llassaletta@salud.madrid.org
  • Valencia, Spain, 46026
    • Hospital Universitario Y Politecnico La Fe
    • Contact: Laura Cavallé Garrido, Dr.; Phone Number: +43577881694; Email: cavallelaura@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Lack of compliance with any inclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bisyllables recognition score in quiet	pre-operative to 5 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bisyllables recognition score in noise		pre-operative to 5 years post-operative
Wearing time	Wearing time in hours of audio processor used together with SONATA 2 cochlear implant	up to 5 years post-operative
Hardware and device parameters	Descriptive summary of which electrode type and audio processor type was used together with a SONATA 2 cochlear implant	up to 5 years post-operative
Demographic information	descriptive summary of age at implantation, date of implantation, gender, type and duration of hearing loss, indications	pre-operative
Complications related to the device or procedure		up to 5 years post-operative
Questionnaire scores	Hearing Implant Sound Quality Index (HISQUI19)	pre-operative to 5 years post-operative
Questionnaire scores	Speech, Spatial, and Qualities of Hearing Scale (SSQ)	pre-operative to 5 years post-operative
Questionnaire scores	Nijmegen Cochlear Implant Questionnaire (NCIQ), LittlEars Auditory Questionnaire (LEAQ), Glasgow Benefit Inventory (GBI)	pre-operative to 5 years post-operative
Questionnaire scores	LittlEars Auditory Questionnaire (LEAQ)	pre-operative to 5 years post-operative
Questionnaire scores	Glasgow Benefit Inventory (GBI)	pre-operative to 5 years post-operative

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: retrospective data collection
• Other Study ID Numbers: MED-EL_CRD_2025_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No