Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Phonic Ear, Inc. — Predicate Candidate Screening

31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

57 daysmedian FDA review time

104 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K043090	EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FI	Phonic Ear, Inc.	2004-12-23	45
K974658	INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRA	Phonic Ear, Inc.	1998-02-25	72
K974287	FM RECEIVER - AUDITORY TRAINER	Phonic Ear, Inc.	1998-02-10	88
K950730	GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)	Phonic Ear, Inc.	1995-06-30	134
K940313	PHONIC EAR	Phonic Ear, Inc.	1994-03-22	57
K923234	PE 400IR, PE 400T, PE 400E	Phonic Ear, Inc.	1992-09-29	90
K922720	GROUP AUDITORY TRAINING SYSTEM	Phonic Ear, Inc.	1992-08-24	80
K912356	GROUP AUDITORY TRAINER,FM RECEIVER	Phonic Ear, Inc.	1991-08-15	79
K893431	AUDITORY TRAINER PE150R FM RECEIVER	Phonic Ear, Inc.	1989-08-21	111
K882409	PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER	Phonic Ear, Inc.	1988-07-05	25
K881099	PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER	Phonic Ear, Inc.	1988-06-07	84
K874304	PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL	Phonic Ear, Inc.	1987-11-20	31
K872473	POST-AURICULAR HEARING AID MODEL PE 805CD2	Phonic Ear, Inc.	1987-07-28	35
K872474	POST-AURICULAR HEARING AID MODEL PE 805 SCD2	Phonic Ear, Inc.	1987-07-28	35
K864672	PHONIC EAR MODELS PE 811CS AND PE 811CST	Phonic Ear, Inc.	1987-02-20	80
K862773	PHONIC EAR, MODEL PE475R	Phonic Ear, Inc.	1986-10-09	79
K862229	PHONIC EAR PE 602 PPCS	Phonic Ear, Inc.	1986-07-22	41
K862162	PHONIC EAR, MODEL PE 1800	Phonic Ear, Inc.	1986-07-18	42
K861857	PHONIC EAR	Phonic Ear, Inc.	1986-06-09	26
K844862	POST-AURICULAR HEARING AID MODEL PE 600PPCH	Phonic Ear, Inc.	1985-04-08	115
K844863	POST-SURICULAR HEARING AID PE 600CD	Phonic Ear, Inc.	1985-03-28	104
K844859	POST-AURICULAR HEARING AID MODEL PE 600 PPC	Phonic Ear, Inc.	1985-03-28	104
K844861	POST-AURICULAR HEARING AID MODEL PE 600PPCL	Phonic Ear, Inc.	1985-03-27	103
K844860	POST-AURICULAR HEARING AID MODEL PE 600CHD	Phonic Ear, Inc.	1985-03-27	103
K840359	POST-AURICULAR HEARING AID	Phonic Ear, Inc.	1984-02-21	26
K832080	PHONIC EAR PE 467R-PE 461T	Phonic Ear, Inc.	1983-08-01	34
K832081	PHONIC EAR PE 845PPC-D	Phonic Ear, Inc.	1983-08-01	34
K830098	PHONIC EAR	Phonic Ear, Inc.	1983-02-01	21
K822779	PHONIC EAR-PE 845-PPC	Phonic Ear, Inc.	1982-10-04	20
K820172	PHONIC EAR MODEL PE 810S	Phonic Ear, Inc.	1982-02-24	34
K813583	PHONIC EAR MODEL PE805CD	Phonic Ear, Inc.	1982-01-12	15

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda