Long-term outcomes of MED-EL SONATA 2 Cochlear Implants in real life
Official title: Longitudinal Outcomes of SONATA 2 Cochlear Implant Recipients: a Retrospective Study
Run by MED-EL Elektromedizinische Geräte GmbH · NCT07697911 · Data updated 2026-11-12
This study looks at long-term results from people who received a SONATA 2 cochlear implant to see how well it works in everyday life.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | MED-EL Elektromedizinische Geräte GmbH Industry-sponsored |
| Locations | 2 sites (Madrid and 1 other locations) |
| Status | Recruiting |
| Started | October 19, 2026 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07697911 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults and potentially children with at least one MED-EL SONATA 2 cochlear implant and a compatible audio processor who have been implanted in routine care.
✕Probably not a fit
Patients without a MED-EL SONATA 2 implant or without compatible equipment or missing essential data may not benefit from the study results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective observational analysis of real-world data from MED-EL SONATA 2 cochlear implant recipients. Data from clinical records will be transferred into CASTOR EDC after ethics approval, including all participants who meet inclusion criteria. The aim is to describe long-term safety and effectiveness in a diverse, routine-care population. No new interventions are performed; the study relies on existing clinical data collected during standard care. Results may inform clinicians and policymakers about real-world outcomes in sensorineural hearing loss with cochlear implantation.
Why it matters
Potential benefit: If successful, the study could provide evidence about the durability and effectiveness of SONATA 2 implants in everyday settings, helping guide future patient care decisions.
How similar studies have gone: Previous real-world observational data on cochlear implants have contributed to understanding long-term outcomes, but specific long-term data for SONATA 2 in diverse populations are limited, making this a valuable addition.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Universitario La Paz
Madrid, Spain Recruiting -
Hospital Universitario y Politécnico La Fe
Valencia, Spain Not yet recruiting
Study contacts
- Study coordinator: Jasmine Rinnofner
- Email: jasmine.rinnofner@medel.com
- Phone: +43577881694
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Perceptual adaptation after cochlear implantation
This trial will try different frequency maps in adults who just received a cochlear implant in one ear to see which map improves sound quality, device use, and speech understanding.
-
Biomarkers in Congenital Hearing Loss: Alpha-Tectorin, IL-10, and Thiol-Disulfide Balance in Children
This observational study tests whether levels of alpha-tectorin, IL-10, and thiol-disulfide balance differ in children with congenital sensorineural hearing loss (with cochlear implants or hearing aids) compared with healthy children.
-
Anatomy-based fitting for single-sided deaf CI users
This study tests whether anatomy-based fitting changes how well adults with single-sided deafness use a cochlear implant to understand speech in noise and to enjoy music.
-
Anatomy-Based Fitting for People with a Cochlear Implant and Hearing Aid
This study tests whether an anatomy-based frequency distribution works better than the default one for adults with a cochlear implant and a contralateral hearing aid.
-
New software to help guide electrode insertion during cochlear implant surgery
A new software tool called OTOGUIDE is being tested to see if it can help surgeons place cochlear implant electrodes more accurately during surgery.
-
Biomarkers linked to congenital CMV using newborn blood spots
Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.