TRUMPET

Basic Information

• Brand Name: TRUMPET
• Primary DI: 08054187380570
• Version / Model: TRUMPET REM & AUD
• Catalog Number: 10969
• Company Name: INVENTIS SRL
• Labeler DUNS: 338454995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 3
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 51aa40f1-f082-4751-8352-b937c470a544

Device Description

Trumpet REM & AUD is - a Real Ear Measurement (REM) system capable of assessing all the in-situ parameters required for a complete hearing aid fitting process, and - a diagnostic audiometer capable of performing pure tone and speech audiometry, in air, free field, and in bone conduction.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWO	Audiometer	Ear, Nose, Throat	874.1050	2
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	874.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37503	Tone audiometer	An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.	No	Active
36909	Ear canal insertion gain measurement instrument	A device that measures the sound pressure level in the ear canal. It is used in the fitting of hearing aids, comparing the results with and without the aid.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08054187380570	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]