16 model rows have no linked premarket submission on 2026-09-07
| Model | Price | SoundScore | Tier | Trace / company | Status |
|---|---|---|---|---|---|
| MDHearing AIR 3 | $297 source | Not available | 4 source | LISTING source · MDHearing Warehouse source | active (2026-09-06) source |
| MDHearing NEO | $297 source | Not available | 4 source | LISTING source · MDHearing Warehouse source | active (2026-09-06) source |
| MDHearing VOLT 4 | $397 source | Not available | 4 source | LISTING source · MDHearing Warehouse source | active (2026-09-06) source |
| Audien Atom 2 | $189 source | Not available | 4 source | UDI source · Budget Hearing Aids, LLC source | active (2026-09-06) source |
| Audien Atom Pro 2 | $289 source | 3.3 source | 4 source | UDI source · Budget Hearing Aids, LLC source | active (2026-09-06) source |
| Audien Ion 2 | $489 source | Not available | 4 source | UDI source · Budget Hearing Aids, LLC source | active (2026-09-06) source |
| Audien Ion Pro 2 | $689 source | Not available | 4 source | UDI source · Budget Hearing Aids, LLC source | active (2026-09-06) source |
| Elehear Beyond Pro | $599 source | 4.2 source | 4 source | UDI source · ELEHEAR Inc. source | active (2026-09-06) source |
| Elehear Beyond | $399 source | 4.3 source | 4 source | UDI source · ELEHEAR Inc. source | active (2026-09-06) source |
| Elehear Delight | $369 source | 4.3 source | 4 source | UDI source · ELEHEAR Inc. source | active (2026-09-06) source |
| JLab Hear OTC | $99.99 source | 3.5 source | 4 source | UDI source · JLab source | active (2026-09-06) source |
| Cearvol Wave | $497 source | 3.9 source | 4 source | LISTING source · SHENZHEN CANNICE TECHNOLOGY CO.,LTD source | active (2026-09-06) source |
| Cearvol Diamond X1 | $289 source | 3.7 source | 4 source | LISTING source · SHENZHEN CANNICE TECHNOLOGY CO.,LTD source | active (2026-09-06) source |
| Yeasound RIC800 | $549 source | 4.7 source | 4 source | UDI source · Yeasound (Xiamen) Hearing Technology Co., Ltd source | active (2026-09-07) source |
| Yeasound RIC700 | $379 source | 4.3 source | 4 source | UDI source · Yeasound (Xiamen) Hearing Technology Co., Ltd source | active (2026-09-07) source |
| Audicus Omni Series 2 | $1,898 source | 4.6 source | 4 source | LISTING source · Audicus source | active (2026-09-07) source |
Open every source
- https://api.fda.gov/device/510k.json
- https://api.fda.gov/device/event.json
- https://apps.apple.com/app/id1244278587
- https://apps.apple.com/app/id6446886717
- https://apps.apple.com/app/id6475083036
- https://apps.apple.com/app/id6479181179
- https://apps.apple.com/app/id6479745160
- https://apps.apple.com/app/id6502378834
- https://apps.apple.com/us/app/audien-ion-pro/id1600000000
- https://audienhearing.com/
- https://audienhearing.com/collections/accessories
- https://audienhearing.com/pages/atom-2-email/
- https://audienhearing.com/pages/limited-warranty
- https://audienhearing.com/policies/refund-policy
- https://audienhearing.com/products/atom-pro-2
- https://audienhearing.com/products/audien-ion-otc-hearing-aids-new
- https://cearvol.com/pages/refund-policy
- https://cearvol.com/products/cearvol-wave-starlight
- https://cearvol.com/products/diamond-x1-white-best-hearing-aids-with-bluetooth
- https://elehear.com/collections/accessories
- https://elehear.com/collections/all
- https://elehear.com/products/beyond-pro
- https://elehear.com/products/elehear-beyond
- https://elehear.com/products/elehear-delight
- https://fcc.report/FCC-ID/2A7JZ002408
- https://fccid.io/2A7JZ
- https://hearingindex.com/methodology
- https://hearingreview.com/hearing-products/hearing-aids/otc/lxe-hearing-announces-wind-down-of-us-operations-affecting-eargo-lexie-and-go-brands
- https://lexiehearing.com/us/
- https://support.apple.com/en-us/HT210386
- https://web.archive.org/web/20260901173819/https://support.apple.com/en-us/106341
- https://web.archive.org/web/20260906210137/https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20088916&pc=ESD
- https://web.archive.org/web/20260906210204/https://fccid.io/2A7JZ
- https://web.archive.org/web/20260906210255/https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254108.pdf
- https://web.archive.org/web/20260906210307/https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230081.pdf
- https://web.archive.org/web/20260906210349/https://hearingreview.com/hearing-products/hearing-aids/otc/lxe-hearing-announces-wind-down-of-us-operations-affecting-eargo-lexie-and-go-brands
- https://web.archive.org/web/20260906210417/https://www.hearingtracker.com/news/eargo-and-lexie-parent-lxe-hearing-begins-u-s-wind-down
- https://web.archive.org/web/20260906210450/https://lexiehearing.com/us
- https://web.archive.org/web/20260906210620/https://www.eargo.com/
- https://web.archive.org/web/20260906210725/https://audienhearing.com/
- https://web.archive.org/web/20260906210816/https://www.hearingtracker.com/news/sales-of-sony-hearing-aids-discontinued-wsa-eyes-next-steps-for-otc-market
- https://web.archive.org/web/20260906210903/https://www.jabraenhance.com/product
- https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254108.pdf
- https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230081.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20088916&pc=ESD
- https://www.audicus.com/product/omni-series-2
- https://www.eargo.com/
- https://www.hearadvisor.com/best-otc-hearing-aids
- https://www.hearadvisor.com/products/audicus-omni-2
- https://www.hearadvisor.com/products/audien-atom-2
- https://www.hearadvisor.com/products/audien-atom-pro-2
- https://www.hearadvisor.com/products/audien-ion-2
- https://www.hearadvisor.com/products/audien-ion-pro-2
- https://www.hearadvisor.com/products/cearvol-diamond-x1
- https://www.hearadvisor.com/products/cearvol-wave
- https://www.hearadvisor.com/products/elehear-beyond
- https://www.hearadvisor.com/products/elehear-beyond-pro
- https://www.hearadvisor.com/products/elehear-delight
- https://www.hearadvisor.com/products/jabra-enhance-select-700
- https://www.hearadvisor.com/products/jlab-hear-otc
- https://www.hearadvisor.com/products/mdhearing-air-3
- https://www.hearadvisor.com/products/mdhearing-neo
- https://www.hearadvisor.com/products/mdhearing-volt-4
- https://www.hearadvisor.com/products/yeasound-ric700
- https://www.hearadvisor.com/products/yeasound-ric800
- https://www.hearingtracker.com/news/eargo-and-lexie-parent-lxe-hearing-begins-u-s-wind-down
- https://www.hearingtracker.com/news/sales-of-sony-hearing-aids-discontinued-wsa-eyes-next-steps-for-otc-market
- https://www.jabraenhance.com/product
- https://www.jlab.com/products/hear-otc-hearing-aid-beige
- https://www.mdhearingaid.com/accessories/
- https://www.mdhearingaid.com/hearing-aids/mdhearing-air/
- https://www.mdhearingaid.com/hearing-aids/mdhearing-neo/v2
- https://www.mdhearingaid.com/hearing-aids/mdhearing-volt/
- https://www.trustpilot.com/
- https://www.walmart.com/ip/20003216517
- https://www.walmart.com/ip/20805306615
- https://www.walmart.com/ip/3697653760
- https://www.yeasound.com/products/yeasound-ric700-hearing-aids-for-seniors-adults-gold
- https://www.yeasound.com/products/yeasound-ric800-otc-hearing-aids