Cochlear ImplantationLORISNCT07697911
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
An observational study of Cochlear Implantation and Sensorineural Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cochlear Implantation, Sensorineural Hearing Loss
- What is being tested?
- Transfer of data of SONATA 2 cochlear implant recipients
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 19 Oct 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- At least one MED-EL SONATA 2 cochlear implant with a compatible MED-EL audio processor
Who cannot join
- Lack of compliance with any inclusion criteria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Luis Lassaletta Atienza, Dr., +34 91 207 1651, llassaletta@salud.madrid.org
- Not yet recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Laura Cavallé Garrido, Dr., +43577881694, cavallelaura@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- Cochlear Implantation, Sensorineural Hearing Loss
- Being tested
- Transfer of data of SONATA 2 cochlear implant recipients
- Keywords
- retrospective data collection
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer of data of SONATA 2 cochlear implant recipientsOther
Data from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC
What is being measured
The primary outcome is the main question the study is designed to answer.
Bisyllables recognition score in quiet
Measured: pre-operative to 5 years post-operative
Secondary outcomes (10)
Bisyllables recognition score in noise
Measured: pre-operative to 5 years post-operative
Wearing time
Wearing time in hours of audio processor used together with SONATA 2 cochlear implant
Measured: up to 5 years post-operative
Device parameter
Descriptive summary of which electrode type was used together with a SONATA 2 cochlear implant
Measured: up to 5 years post-operative
Device parameter
Descriptive summary of which audio processor type was used together with a SONATA 2 cochlear implant
Measured: up to 5 years post-operative
Demographic information
descriptive summary of demographics
Measured: pre-operative
Complications related to the device or procedure
Measured: up to 5 years post-operative
Questionnaire scores
Hearing Implant Sound Quality Index (HISQUI19). Total score range from 19 to 133 points. The higher the score the better the outcome.
Measured: pre-operative to 5 years post-operative
Questionnaire scores
Speech, Spatial, and Qualities of Hearing Scale (SSQ). Total score range from 0 to 10 points. The higher the score the better the outcome.
Measured: pre-operative to 5 years post-operative
Questionnaire scores
LittlEars Auditory Questionnaire (LEAQ). Total score range from 0 to 35 points. The higher the score the better the outcome.
Measured: pre-operative to 5 years post-operative
Questionnaire scores
Glasgow Benefit Inventory (GBI). Total score range from -100 to +100points. The higher the score the better the outcome.
Measured: pre-operative to 5 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start19 Oct 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantationStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697911
- Sponsor's protocol ID
- MED-EL_CRD_2025_01
- Acronym
- LORIS
- Status last verified
- Nov 2026
- First submitted
- 24 Jun 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Outcomes of SONATA 2 Cochlear Implant Recipients: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07697911
- Acronym / sponsor ID
- LORIS / MED-EL_CRD_2025_01
- Conditions
- Cochlear Implantation, Sensorineural Hearing Loss
- Keywords
- retrospective data collection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- At least one MED-EL SONATA 2 cochlear implant with a compatible MED-EL audio processor
Key exclusion criteria (1 listed)
- Lack of compliance with any inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfer of data of SONATA 2 cochlear implant recipientsData from SONATA 2 cochlear implant recipients is transferred to CASTOR EDC | Other | – |
Primary outcome
Bisyllables recognition score in quiet
Time frame: pre-operative to 5 years post-operative
10 secondary outcomes
Bisyllables recognition score in noise
Time frame: pre-operative to 5 years post-operative
Wearing time
Time frame: up to 5 years post-operative
Device parameter
Time frame: up to 5 years post-operative
Device parameter
Time frame: up to 5 years post-operative
Demographic information
Time frame: pre-operative
Complications related to the device or procedure
Time frame: up to 5 years post-operative
Questionnaire scores
Time frame: pre-operative to 5 years post-operative
Questionnaire scores
Time frame: pre-operative to 5 years post-operative
Questionnaire scores
Time frame: pre-operative to 5 years post-operative
Questionnaire scores
Time frame: pre-operative to 5 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implantation
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
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Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
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Mi2000 TICI - Post-market Implantation Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implantation and Sensorineural Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Rinnofner (+43577881694, jasmine.rinnofner@medel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bisyllables recognition score in quiet (time frame: pre-operative to 5 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.