
From FDA Clearance to 1 Billion Views: How This Medical Device Startup Went Viral
Delta: HealthTech Innovators
Outro
Host thanks Sahil and closes the episode with final remarks and gratitude for sharing the Otoset story.
When Sahil and his brother started Otoset in their mid-20s, they had no idea their FDA-cleared ear cleaning device would generate over 1 billion social media views and force them to completely pivot their business model.
In this episode, Sahil shares the unexpected journey from building a B2B medical device company to creating "the front door to ear care", a direct-to-consumer healthcare network serving 40 million Americans with chronic ear wax issues.
🔑 KEY TAKEAWAYS:
→ How they became some of the youngest founders to get FDA 510(k) clearance
→ The unexpected social media virality that changed everything
→ Why they pivoted from partner clinics to owning their own locations
→ Marketing strategies: organic content, influencers, and patient education
→ The critical role of FDA clearance as a competitive differentiator
→ Building credibility before scaling consumer marketing
→ Finding the right mentors in healthcare entrepreneurship
đź’ˇ WHO THIS IS FOR:
âś“ HealthTech & MedTech founders navigating FDA pathways
âś“ Startups exploring direct-to-consumer healthcare models
âś“ Entrepreneurs learning to leverage social media for medical products
âś“ Anyone interested in the consumerization of healthcare
📊 BY THE NUMBERS:
- 40 million Americans affected by ear wax buildup
- 1 billion+ views across social media
- $99 cash-pay model (first treatment)
- 20-30 patients/day in company-owned clinics
- Expanding to 50+ major metros
Timestamps:
00:00 - Introduction: The Brother's Ear Wax Problem
01:21 - What is Otoset? The First FDA-Cleared Ear Cleaning Device
03:22 - Why FDA Clearance Matters & How They Got It
06:56 - The Unexpected Social Media Explosion
08:55 - The Strategic Pivot: B2B Device to D2C Healthcare Network
11:36 - Business Model: $99 Cash-Pay & Building Owned Clinics
15:18 - Beyond Ear Care: Hearing Health & Expansion Plans
17:15 - Marketing Strategy: Organic, Influencers & Patient Education
20:33 - Building Credibility Before Scaling Consumer Marketing
22:35 - Biggest Lesson: Find Healthcare Entrepreneur Mentors Early
24:33 - Final Thoughts & Key Takeaways
📌 Key Resources & Links
đź”— Otoset Website: https://otoset.com/
đź”— Otoset Linkedin: https://www.linkedin.com/company/visitallears/
🏥 Find a Certified Clinic: https://otoset.com/pages/find-clinic
đź’Ľ Connect with Sahil: https://www.linkedin.com/in/sahildiwan/


