FDA applicant
Nu-Ear Electronics
FDA records 10 decisions for Nu-Ear Electronics (San Diego, CA) in 1994: 10 510(k) clearances. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nu-Ear Electronics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Nu-Ear Electronics since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Nu-Ear Electronics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report