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Clinical Trials in Spain / NCT06930781
Recruiting Observational

Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)

NCT06930781 · tracked via the Priya Life Science Spain tracker
Sponsor
Oticon Medical
Phase
Observational
Started
2025-05-07
Last updated
2026-07-08

Condition(s) studied

Hearing LossBone Anchored Hearing Aids

Investigational drug(s) / intervention(s)

Ponto implantation

Ponto implantation: Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction.

Study summary

This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards * Signed informed consent (applicable for subjects answering questionnaires) Exclusion Criteria: * No exclusion criteria have been set for this observational investigation

Primary outcome measure(s)

  • Intraoperative complications at surgery — During the Ponto-implantation surgery

Trial sites (6)

FacilityCityRegionStatus
Northern California Veterans Affairs Healthcare System Sacramento California Recruiting
Clinical Hospital from the Ribeirão Preto Medical School São Paulo São Paulo Active Not Recruiting
Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Recruiting
Hospital Virgen de las Nieves Granada Andalusia Active Not Recruiting
Sunderby Sjukhus Luleå Norrbotten County Active Not Recruiting
Skåne University Hospital Lund Skåne County Active Not Recruiting

More Oticon Medical trials in Spain

Pediatric Expansion Study of the Sentio System Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06930781 on ClinicalTrials.gov ↗ ← All trials in Spain