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NCT03541967
Comparison of a New Bone Conduction Hearing System to a Osteo-integrated Bone Conduction Hearing Aid on a Softband
NA trial testing ADHEAR and PONTO 3 SUPER POWER on softband hearing aids in Conductive Hearing Loss. Withdrawn.
15 July 2019
Quick facts
| Lead sponsor | MED-EL Elektromedizinische Geräte GesmbH |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Start date | 15 July 2018 |
| Primary completion | 15 July 2019 |
| Estimated completion | 15 July 2019 |
Drugs / interventions tested
- ADHEAR and PONTO 3 SUPER POWER on softband hearing aids
Conditions studied
- Conductive Hearing Loss — all drugs for Conductive Hearing Loss →
Sponsor
MED-EL Elektromedizinische Geräte GesmbH — full company profile →
Who can join
Adults 5 to 15, any sex, with Conductive Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Main objectives * The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain. * The second main objective of the study is to evaluate the superiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort. Secondary objectives * Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband. * Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER on softband. * Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER POWER on softband. * Evaluate the satisfaction and use of ADHEAR.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03541967
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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 NCT03541967 (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 June 2019
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/NCT03541967.
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