Facility

PATH

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008111228
Establishment type	Manufacture Medical Device
Location	Landsberger Strasse 65 Germering Bavaria, DE 82110
Registration status	Active · expires 2026
Parent company	PATH (owner-operator 10042983)
Brand names	Sentiero - DD45/contra,HDA280,HDA300,B71,B81,PIEP/Mono(w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB04,AB05,AB06); AuDX PRO - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06); NavPRO ONE - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06); AuDX - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06); AuDX PRO FLEX - DD45/contra,HDA280,HDA300,B71,B81,PIEP/Mono(w.FoamTips),,AB01,AB04,AB03,AB05,AB06); TY-101 - DD45/contra,DD65/DD65V2,HDA300,B81,PIEP/Mono(w.FoamTips),AB01,AB04,AB03,AB05,AB06)

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (3)

Audiometer
Product code EWO (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.1050
Tester, Auditory Impedance
Product code ETY (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.1090
Stimulator, Auditory, Evoked Response
Product code GWJ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1900

Recalls & enforcement

Class IIOngoing2025-11-06
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
Class IIOngoing2023-09-26
Affected lots of product may experience technical distortions to a greater extent than expected.

FDA inspections (1)

NAI2017-05-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by PATH

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PATH (FEI 3008111228) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008111228-path/

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