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NCT05955469
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
NA trial testing FS4 then TFS4 (cochlear implant) in Sensorineural Hearing Loss, Bilateral in 20 participants. Currently enrolling.
1 January 2027
Quick facts
| Lead sponsor | MED-EL Elektromedizinische Geräte GesmbH |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 5 November 2024 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 January 2027 |
| Sites | 1 location across France |
Drugs / interventions tested
- FS4 then TFS4 (cochlear implant)
- TFS4 then FS4 (cochlear implant)
Conditions studied
- Sensorineural Hearing Loss, Bilateral — all drugs for Sensorineural Hearing Loss, Bilateral →
- Bilateral Hearing Loss — all drugs for Bilateral Hearing Loss →
Sponsor
MED-EL Elektromedizinische Geräte GesmbH — full company profile →
Who can join
18 and older, any sex, with Sensorineural Hearing Loss, Bilateral or Bilateral Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise. Secondary objectives: Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05955469
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sensorineural Hearing Loss, Bilateral
Currently open trials in the same condition.
- NCT06737185 — Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms · NA · recruiting
- NCT06723262 — Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting · NA · recruiting
- NCT05898659 — Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization · NA · recruiting
- NCT05402813 — Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes · recruiting
- NCT04591093 — Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy · NA · recruiting
Other MED-EL Elektromedizinische Geräte GesmbH trials
Trials by the same sponsor.
- NCT07213505 — This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipien · NA · recruiting
- NCT06817928 — Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Inf · completed
- NCT06737185 — Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms · NA · recruiting
- NCT06723262 — Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting · NA · recruiting
- NCT06634784 — Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old: This Study Looks at Children Under Five W · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05955469 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MED-EL Elektromedizinische Geräte GesmbH
- Last refreshed: 20 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05955469.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing