By brand

Audicus

3 products in our database · Average MSRP $1,648

Some Audicus products have ambiguous FDA pathways.

One or more Audicus products claim to be "FDA-registered Class I" but have no specific 510(k) underAudicus'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 with publishReady: false. We are reaching out to Audicus for K-number disclosure.

FDA regulatory pathways in this brand

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.

Affiliate program

Audicus direct (no major affiliate)

Commission: TBD

We may earn a commission if you purchase through links on this page, at no extra cost to you. We label every product's regulatory pathway honestly regardless of affiliate value.

Available products

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

Audicus

Wave 2

FDA-registered only — pathway unverified

Severity range: 26–60 dB HL
Form factor: RIC
Battery: Rechargeable
Bluetooth: App control
Trial: 45 days
Warranty: 12 months

Audicus is primarily a refurb/repackager — openFDA shows no 510(k) under Audicus's name. The Wave 2 is sold as 'FDA-registered Class I' (establishment registration only). Lower regulatory rigor than QUH self-fit or QDD prescription products at similar price points.

Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.

Audicus

Spirit 2

FDA-registered only — pathway unverified

Severity range: 26–60 dB HL
Form factor: RIC
Battery: Rechargeable
Bluetooth: App control
Trial: 45 days
Warranty: 12 months

Audicus is primarily a refurb/repackager — openFDA shows no 510(k) under Audicus for the Spirit 2. The product is sold as 'FDA-registered Class I' (establishment registration only). The optional Premier subscription tier ($99/mo + $249 setup) bundles supplies and remote care, which materially raises the 5-year TCO vs comparable QUH self-fit options. Honest comparison shopping recommended.

Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.

Audicus

Omni 2

FDA-registered only — pathway unverified

Severity range: 26–60 dB HL
Form factor: RIC
Battery: Rechargeable
Bluetooth: App control
Trial: 45 days
Warranty: 12 months

Premium Audicus with Premier subscription option. No 510(k) under Audicus in openFDA. Flag pending verification.

Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.

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.