Model record · frozen 2026-09-07

MDHearing VOLT MAX 2: $597, SoundScore 3 (2026-09-07), tier 2, app updated 82 days ago, light GREEN

A · sound

dominance gap usd	$497.01 source
dominance reason	Not available
dominance status	dominated source
dominated by	jlab-hear-otc source
frontier	No source
ht score	Not available
ht url	Not available
platform requirement	Not available
price per point	199 source
soundscore consistent	Not available
soundscore date	2026-09-07 source
soundscore fit mode	product_card_headline source
soundscore grade	B source
soundscore headline card	3 source
soundscore hearadvisor	3 source
soundscore initial	Not available
soundscore leaderboard	Not available
soundscore method version	HearAdvisor SoundScore (product-card headline), snapshot 2026-09-07 source
soundscore snapshot date	2026-09-07 source
soundscore source page	product_card source
soundscore tuned	Not available
soundscore url	https://www.hearadvisor.com/products/mdhearing-voltmax source
soundscore v0 csv	3.1 source

clearance type	510k source
decision date	2022-08-04 source
evidence tier	2 source
evidence tier label	tier 2: public premarket decision evidence linked source
has own clinical study	Yes source
k map confidence	medium: MDHearing Smart app clearance source
k number	K220303 source
predicate k numbers	DEN180026 source
regulatory path	510(k) source
self fitting claim source	Not available

app	Yes source
battery life hours	Not available
battery type	li-ion source
bluetooth	Yes source
brand	MDHearing source
fda category	OTC-self-fitting source
fda codes	QUF source
fda company	MDHearing Warehouse source
fda listing name	MDHearing AIR 3 source
fda trace	LISTING source
fda udi hits	0 source
form factor	BTE source
id	mdhearing-volt-max-2 source
mfi listed	No source
model	VOLT MAX 2 source
notes	Remote professional fine-tuning is included \| MDHearing accessories: domes $7.50–19.99 (variety pack $19.95 taken as 1/yr), wax guards $15 (1 pack/yr assumed), charger $99.99, batteries 312 $6.95–32.50; protection plan price not listed; usage_assumed source
price basis	pair source
rechargeable	Yes source
release year	Not available
self fitting	Yes source
verified	Yes source

flag safety	0 source
maude caveat	FDA: MAUDE is incomplete, may contain duplicates and cannot establish causation or frequency source
maude events brand	0 source
maude query text	brand_name:"MDHearing" AND generic_name:"hearing aid" source
maude scope	brand-name query; counts, not rates; no OTC-code filter source

clinical design	RCT source
clinical n	64 source
clinical outcomes	APHAB; SSQ-12; QuickSIN; REAR/REAG source
clinical result summary	Self-fit outcomes were non-inferior to professional fit on subjective and objective benefit; no AEs/SAEs. source
own bench usability reported	No source
relies on predicate clinical	No source

price date	2026-09-06 source
price history current usd	$597 source
price history max usd	$597 source
price history min usd	$597 source
price history n snapshots	1 source
price history noise excluded	0 source
price pair amazon usd	Not available
price pair bestbuy usd	Not available
price pair brand usd	$597 source
price pair costco usd	Not available
price pair walmart usd	Not available