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NCT05086809
Investigation of an Updated Bone-anchored Sound Processor
NA trial testing Device A in Hearing Loss in 15 participants. Completed in 13 December 2021.
13 December 2021
Quick facts
| Lead sponsor | Oticon Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 15 |
| Start date | 30 September 2021 |
| Primary completion | 13 December 2021 |
| Estimated completion | 13 December 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Device A
- Device B
Conditions studied
- Hearing Loss — all drugs for Hearing Loss →
- Hearing Loss, Conductive — all drugs for Hearing Loss, Conductive →
- Hearing Loss, Mixed — all drugs for Hearing Loss, Mixed →
- Hearing Disorders — all drugs for Hearing Disorders →
Sponsor
Oticon Medical
Who can join
18 and older, any sex, with Hearing Loss or Hearing Loss, Conductive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor. The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.
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 NCT05086809
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Device A
Trials testing the same drug.
- NCT07501312 — Remote Microphone Performance Comparison in Adults With Hearing Loss · NA · enrolling by invitation
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 Oticon Medical trials
Trials by the same sponsor.
- NCT07294976 — Evaluation of Actual Maximum Gain in Bone Anchored Devices · NA · recruiting
- NCT06930781 — Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-O · recruiting
- NCT06976086 — Pediatric Expansion Study of the Sentio System · NA · recruiting
- NCT06421766 — Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures · completed
- NCT06638840 — Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband. · 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 NCT05086809 (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 Oticon Medical
- Last refreshed: 20 April 2022
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/NCT05086809.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing