# ESD: Hearing Aid, Air-Conduction, Prescription

- Device class: 1; regulation: 21 CFR 874.3300; FDA's rule: 510(k) exempt
- FDA decisions: 1,367
- 510(k) review time 2021–2025: median 202 days (middle half 202–202)
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1995: 106
- 1996: 82
- 1997: 79
- 1998: 3
- 1999: 1
- 2001: 1
- 2002: 1
- 2008: 1
- 2013: 1
- 2024: 1

## Most-cited predicates
- K003558: Tci Combi (Tinnitus Control Instrument Combination) (2001), cited by 5
- K974751: Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic (1998), cited by 3
- K021867: Insound XT Series Hearing Aid (2002), cited by 3
- K921725: Philip XP Series, in-the Canal Hearing Aid (1992), cited by 3
- K964603: Articular Hearing Aids (1996), cited by 3
- K940667: Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid (1994), cited by 3
- K960804: Miracle Ear & Audiotone Model Ite/Itc/Cic (1996), cited by 2
- K884288: Hearing Aid, Unitron Bte Model UM60-AGC0 (1989), cited by 2
- K923784: Starkey SM Series Bte Hearing Aids (1992), cited by 2
- K943788: Resound Personal Hearing System (1994), cited by 2

Source page: https://510kreport.com/product-code/ESD
Data by year (CSV): https://510kreport.com/product-code/ESD.csv