🏛️ Verified NIH Record • Updated 2026-07-07

Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR) (NCT06930781)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Oticon Medical

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Northern California Veterans Affairs Healthcare System — Sacramento, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (6 Sites)

  • Northern California Veterans Affairs Healthcare System — Sacramento, California
  • Clinical Hospital from the Ribeirão Preto Medical School — São Paulo, São Paulo
  • Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia
  • Hospital Virgen de las Nieves — Granada, Andalusia
  • Sunderby Sjukhus — Luleå, Norrbotten County
  • Skåne University Hospital — Lund, Skåne County

📞 Contact the Study Coordinator

Phone: +46 70-149 25 03

Email: srld@oticonmedical.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗