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MDHearing

5 products in our database · Average MSRP $577

Some MDHearing products have ambiguous FDA pathways.

One or more MDHearing products claim to be "FDA-registered Class I" but have no specific 510(k) underMDHearing's name in the openFDA database. This could be (a) a ride-on of a contract manufacturer's clearance (undisclosed), or (b) establishment registration only. Before publishing pricing or pushing these as cleared OTC hearing aids, we've flagged them as pending verification. We are reaching out to MDHearing for K-number disclosure. What the FDA pathways mean →

FDA regulatory pathways in this brand

Prescription self-fit, sold as OTC

Prescription self-fit (product code QDD) sold as OTC under 21 CFR 800.30 self-certification. The underlying 510(k) is Rx-cleared.

FDA-registered only — pathway unverified

Brand claims 'FDA-registered Class I' but has no specific 510(k) under their name. Establishment registration only — verify pathway with manufacturer before purchase.

New to these labels? All 9 FDA pathways, decoded in plain English.

Available products

Sorted by price (low to high). All pricing verified July 2026.

MDHearing Volt 4

MDHearing

Volt 4

FDA-registered only — pathway unverified
Severity range
26–60 dB HL
Form factor
BTE-mini
Battery
Rechargeable
Bluetooth
No
Trial
60 days
Warranty
12 months

MDHearing markets the Volt 4 as 'FDA-registered Class I.' That is establishment-level registration, not a product-specific 510(k) clearance. openFDA shows no Volt 4 510(k) under MDHearing's name. The product is legal to sell as a Class I device; it is not equivalent to a QUH self-fit or QDD prescription clearance. Lower regulatory rigor than the MDHearingAid Smart (K220303) in MDHearing's own lineup.

MDHearing Neo XS

MDHearing

Neo XS

FDA-registered only — pathway unverified
Severity range
26–40 dB HL
Form factor
ITE
Battery
Rechargeable
Bluetooth
No
Trial
60 days
Warranty
12 months

Mild-loss-only ITE marketed as 'FDA-registered Class I' (establishment registration only, not a product-specific 510(k)). Lower regulatory rigor than QUH self-fit or QDD prescription clearances. For mild loss specifically, FDA-cleared OTC options like Lexie Lumen ($299) or Apple AirPods Pro 2 HAF ($199) are similarly priced with verified pathway.

MDHearing Air 3

MDHearing

Air 3

FDA-registered only — pathway unverified
Severity range
26–40 dB HL
Form factor
ITE
Battery
Disposable
Bluetooth
No
Trial
60 days
Warranty
12 months

Entry-tier MDHearing on size-13 disposable batteries. Marketed as 'FDA-registered Class I' — establishment registration only, not a product-specific 510(k). Cheapest hearing aid in our database at $297; the regulatory pathway is the trade-off vs the FDA-cleared OTC alternatives at similar price.

MDHearing Volt Max 2

MDHearing

Volt Max 2

FDA-registered only — pathway unverified
Severity range
26–60 dB HL
Form factor
BTE-mini
Battery
Rechargeable (20 hr)
Bluetooth
App + smart features
Trial
60 days
Warranty
12 months

MDHearing markets the Volt Max 2 as 'Class II self-fitting,' but openFDA shows no product-specific 510(k) under MDHearing for this model. The MDHearingAid Smart (K220303) is a distinct, separately-cleared product. The Volt Max 2 appears to be either a ride-on of an undisclosed contract manufacturer's clearance or a Class I establishment-only registration. Buyer should be aware the regulatory pathway is less rigorous than an FDA-cleared OTC self-fit (QUH) at this price tier.

MDHearing MDHearingAid Smart

MDHearing

MDHearingAid Smart

Prescription self-fit, sold as OTC
Severity range
26–60 dB HL
Form factor
BTE-mini
Battery
Rechargeable (20 hr)
Bluetooth
App + smart features
Trial
60 days
Warranty
12 months

The ONLY MDHearing product with a verified 510(k) under MDHearing's name (K220303, product code QDD — prescription self-fit, sold OTC under 21 CFR 800.30 self-certification). Other MDHearing models (Air/Neo/Volt/Volt Max) are 'FDA-registered Class I' only with no specific 510(k).

Other ways to find your hearing aid

Run your audiogram through the interpreter for personalized device-class + product matches. Identify your Costco Kirkland if you already own one. Browse by severity if you know your PTA.

Last reviewed July 2026. HearingAidMatch is not affiliated with MDHearing. Regulatory pathway labels per openFDA classification database.
Prescription self-fit (product code QDD) sold as OTC under 21 CFR 800.30 self-certification. The underlying 510(k) is Rx-cleared. | Brand claims 'FDA-registered Class I' but has no specific 510(k) under their name. Establishment registration only — verify pathway with manufacturer before purchase.