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NCT04890145
The RW-Precision-Coupler Clinical Investigation
NA trial testing RW-Precision-Coupler in Hearing Loss in 5 participants. Completed in 26 November 2024.
26 November 2024
Quick facts
| Lead sponsor | MED-EL Elektromedizinische Geräte GesmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 19 May 2021 |
| Primary completion | 26 November 2024 |
| Estimated completion | 26 November 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- RW-Precision-Coupler
Conditions studied
- Hearing Loss — all drugs for Hearing Loss →
Sponsor
MED-EL Elektromedizinische Geräte GesmbH — full company profile →
Who can join
18 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The RW-Precision-Coupler Clinical Investigation is prospective, non-randomized, open label, single subjects repeated measures, longitudinal monocentric trial. The primary aim of this pre-market clinical investigation is to evaluate the clinical performance and safety of VSB together with the VSB RWP-Coupler in the treatment of hearing loss. As secondary aims are to evaluate the clinical performance of VSB together with RWP-Coupler by measuring Sound Field audiometry (SF), to evaluate the safety of VSB together with RWP-Coupler by measuring bone conduction (BC) thresholds and collecting and assessing adverse events.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04890145
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hearing Loss
Currently open trials in the same condition.
- NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation · NA · recruiting
- NCT07506408 — Randomised Study of Web-Based Auditory Training With Varying Perceptual and Cognitive Demands on Training Gains and Gene · NA · recruiting
- NCT07218913 — Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III · Phase 1 · recruiting
- NCT07414329 — Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit · NA · recruiting
- NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · 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
- NCT05955469 — Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting · NA · recruiting
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 NCT04890145 (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: 3 December 2024
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/NCT04890145.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing