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Tympanic Membrane Direct Contact Hearing Aid

FDA product code PLK · Class 2 · Ear, Nose, Throat

41

Registered devices

3

Adverse events

0

Recalls

3

510(k) clearances

Devices with this code

Earlens Light Driven Hearing Aid, Monaural, Right — EARLENS CORPORATION Earlens ELF USB — EARLENS CORPORATION Earlens Contact Hearing Solution, Monaural, Right — EARLENS CORPORATION Disposable Dual Action Tissue Closure Device — Micro-Tech (Nanjing) Co., Ltd.Earlens ELF USB — EARLENS CORPORATION Earlens Contact Hearing Solution, Monaural, Left — EARLENS CORPORATION Earlens Tympanic Lens, Right — EARLENS CORPORATION Earlens Ear Tip — EARLENS CORPORATION Earlens Tympanic Lens — EARLENS CORPORATION Earlens Fidelity Software — EARLENS CORPORATION Earlens Ear Tip, Right — EARLENS CORPORATION Earlens Ear Tip, Binaural — EARLENS CORPORATION Earlens Contact Hearing Solution, Binaural — EARLENS CORPORATION Disposable Dual Action Tissue Closure Device — Micro-Tech (Nanjing) Co., Ltd.Earlens Tympanic Lens — EARLENS CORPORATION Disposable Dual Action Tissue Closure Device — Micro-Tech (Nanjing) Co., Ltd.Earlens Processor & Light Tip — EARLENS CORPORATION Earlens Processor — EARLENS CORPORATION Disposable Dual Action Tissue Closure Device — Micro-Tech (Nanjing) Co., Ltd.Earlens Processor — EARLENS CORPORATION Earlens Processor, Champagne — EARLENS CORPORATION Earlens Ear Tip, Left — EARLENS CORPORATION Earlens Wireless Updater — EARLENS CORPORATION Earlens Charger — EARLENS CORPORATION

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.