Official-document index

22 FDA decisions, field by field

Tier follows M2. A blank cell means the frozen document extraction did not state one unambiguous value.

Decision	Tier	n	Design	Outcomes	Electroacoustics	Document
DEN180026 Bose® Hearing Aid	1	75	comparative	sound quality preference; QuickSIN; APHAB; SSQ-12; real-ear gain	ANSI/CTA 2051; ANSI/ASA S3.22	Open FDA document
DEN230081 Hearing Aid Feature	1	118	comparative	IOI-HA; QuickSIN; real-ear measure gain	ANSI/CTA 2051:2017	Open FDA document
K211008 Bose SoundControl Hearing Aids	3	Not available	none	predicate APHAB/QuickSIN/SSQ-12; subject-device REAR validation	ANSI/ASA S3.22:2014	Open FDA document
K212609 BHA100 Series Braun Clear Hearing Aid	2	80	RCT	audiometric thresholds; REM; COSI	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017; IEC 60118-13:2019	Open FDA document
K213424 Jabra Enhance Plus	2	38	comparative	REAR; APHAB; QuickSIN; sound preference	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K220303 MDHearing Smart Hearing Aid	2	64	RCT	APHAB; SSQ-12; QuickSIN; REAR/REAG	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K220403 Vibe SF Self-Fitting Hearing Aid	2	28	RCT	APHAB; SSQ-12; QuickSIN; real-ear gain; EMA	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K221052 Self-Fitting hearing aids	2	36	RCT	REAG; APHAB; speech recognition threshold in noise	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K221064 Nuheara IQbuds 2 PRO Hearing Aid	2	43	single-arm	REIG; APHAB; SSQ-12; speech-in-noise	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K221698 Eargo Self-Fitting Hearing Aids	2	33	RCT	audiometric thresholds; REAR; APHAB; speech-in-noise; sound quality	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K223137 Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application	2	64	RCT	APHAB; IOI-HA; QuickSIN; digits-in-noise; in-situ thresholds	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K223848 Intrisound Tuned Lumen 155 Hearing Aids	2	41	RCT	audiometric thresholds; REAR; COSI; IOI-HA	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K223911 Lumen 155-SF	2	92	RCT	satisfaction; APHAB; SSQ-12; simulated REM	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K230538 All-Day Clear Slim ADCS1 Hearing Aid; All-Day Clear ADC1 Hearing Aid	2	44	RCT	APHAB; QuickSIN; REAR; comfort	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K231550 Sontro OTC Hearing Aids	2	29	comparative	REAR; APHAB; QuickSIN	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K233464 WSA Self-Fitting Hearing Aid Gen 2	3	Not available	none	predicate clinical validation; subject bench electroacoustics	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K233747 Concha Sol Hearing Aids	2	21	RCT	QuickSIN; APHAB	ANSI/ASA S3.22:2014; ANSI/CTA 2051	Open FDA document
K243150 Nuance Audio Hearing Aid Software	2	Not available	single-arm	REAR/insertion gain; speech-in-noise; IOI-HA	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017	Open FDA document
K251208 Tuned Self-Fitting Mobile App	2	Not available	comparative	audiometric thresholds; REAR; IOI-HA	Not available	Open FDA document
K254044 Hearing assist	2	142	comparative	IOI-HA; QuickSIN; real-ear insertion gain	ANSI S3.22; ANSI/CTA 2051	Open FDA document
K254108 Jabra Enhance Select Self-fit	3	Not available	none	predicate APHAB/QuickSIN/REAR; subject insertion-gain bench comparison	ANSI/ASA S3.22:2014; ANSI/CTA 2051:2017; IEC 60118-0:2022	Open FDA document
K261187 Hearing Aid Feature	2	103	comparative	APHAB; QuickSIN; REM/achieved gain	Not available	Open FDA document

Exempt rows

These model records follow a documented exempt route in the frozen mapping and do not receive an inferred submission.

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