Phonic Ear, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Phonic Ear, Inc.” (first 1982, latest 2004), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 16 | 16 |
| EPF | Hearing Aid, Group And Auditory Trainer | 12 | 12 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | 2 |
| LZI | Device, Assistive Listening | 1 | 1 |
Review panels
- Ear, Nose and Throat (31)
Most recent Phonic Ear, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043090 | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS | LZI | 2004-12-23 | 45 |
| K974658 | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT | EPF | 1998-02-25 | 72 |
| K974287 | FM RECEIVER - AUDITORY TRAINER | EPF | 1998-02-10 | 88 |
| K950730 | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) | EPF | 1995-06-30 | 134 |
| K940313 | PHONIC EAR | EPF | 1994-03-22 | 57 |
| K923234 | PE 400IR, PE 400T, PE 400E | EPF | 1992-09-29 | 90 |
| K922720 | GROUP AUDITORY TRAINING SYSTEM | EPF | 1992-08-24 | 80 |
| K912356 | GROUP AUDITORY TRAINER,FM RECEIVER | EPF | 1991-08-15 | 79 |
| K893431 | AUDITORY TRAINER PE150R FM RECEIVER | EPF | 1989-08-21 | 111 |
| K882409 | PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER | EPF | 1988-07-05 | 25 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Phonic Ear, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Phonic Ear, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Phonic Ear, Inc.” (first 1982, latest 2004), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Phonic Ear, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phonic Ear, Inc. is 57 days.
Which FDA product codes appear under Phonic Ear, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 16); EPF (Hearing Aid, Group And Auditory Trainer, 12); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 2).
Next steps
- See all 31 Phonic Ear, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Phonic Ear, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.