By brand
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 as pending verification. We are reaching out to Audicus for K-number disclosure. What the FDA pathways mean →
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.
Sorted by price (low to high). All pricing verified July 2026.
Audicus
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.
Audicus
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.
Audicus
Premium Audicus with Premier subscription option. No 510(k) under Audicus in openFDA. Flag pending verification.
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.