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NCT Number: NCT07697911

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

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.

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Key information

Conditions

Cochlear Implantation Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Sensorineural Hearing Loss Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario La Paz, Madrid, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transfer of data of SONATA 2 cochlear implant recipients

Other

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

Primary outcomes

  1. Bisyllables recognition score in quiet

    Time frame: pre-operative to 5 years post-operative

Secondary outcomes

  1. Bisyllables recognition score in noise

    Time frame: pre-operative to 5 years post-operative

  2. Wearing time

    Time frame: up to 5 years post-operative

    Wearing time in hours of audio processor used together with SONATA 2 cochlear implant

  3. Device parameter

    Time frame: up to 5 years post-operative

    Descriptive summary of which electrode type was used together with a SONATA 2 cochlear implant

  4. Device parameter

    Time frame: up to 5 years post-operative

    Descriptive summary of which audio processor type was used together with a SONATA 2 cochlear implant

  5. Demographic information

    Time frame: pre-operative

    descriptive summary of demographics

  6. Complications related to the device or procedure

    Time frame: up to 5 years post-operative

  7. Questionnaire scores

    Time frame: pre-operative to 5 years post-operative

    Hearing Implant Sound Quality Index (HISQUI19). Total score range from 19 to 133 points. The higher the score the better the outcome.

  8. Questionnaire scores

    Time frame: pre-operative to 5 years post-operative

    Speech, Spatial, and Qualities of Hearing Scale (SSQ). Total score range from 0 to 10 points. The higher the score the better the outcome.

  9. Questionnaire scores

    Time frame: pre-operative to 5 years post-operative

    LittlEars Auditory Questionnaire (LEAQ). Total score range from 0 to 35 points. The higher the score the better the outcome.

  10. Questionnaire scores

    Time frame: pre-operative to 5 years post-operative

    Glasgow Benefit Inventory (GBI). Total score range from -100 to +100points. The higher the score the better the outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Jasmine Rinnofner

CONTACT

[email protected]

+43577881694

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Registry information

Official study title

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

Acronym: LORIS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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