Home / Companies / Magnatone Hearing Aid Corp.

Magnatone Hearing Aid Corp.

FDA Regulatory Profile

Magnatone Hearing Aid Corp. has 0 FDA recalls, 4 inspections, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 14, 2025 · VAI
Latest 510(k)
Nov 19, 1997

Reviewing Magnatone Hearing Aid Corp. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Magnatone Hearing Aid Corp. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances8Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 14, 2025Casselberry, FLDevicesVoluntary Action Indicated (VAI)1044692
Dec 10, 2019Casselberry, FLDevicesNo Action Indicated (NAI)1044692
Jul 14, 2017Casselberry, FLDevicesNo Action Indicated (NAI)1044692
Jun 27, 2016Casselberry, FLDevicesVoluntary Action Indicated (VAI)1044692

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 1044692Casselberry, FL4Jul 14, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K973861FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46…Nov 19, 1997
K973665MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I…Nov 4, 1997
K944241MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AIDNov 16, 1994
K911183NHS 2044P BODY AID, HEARING AIDJul 9, 1991
K911174NHS 2009SP HEARING AIDMay 9, 1991
K911182NNHS 2050 SERIES (2055W-2054PP) HEARING AIDSMay 9, 1991
K890525INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTAMay 19, 1989
K852656MODEL M HEARING AIDDec 27, 1985

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.