Hearing Aid, Air Conduction, Transcutaneous System

Product Code: NIX

Ear Nose & Throat Sonic Medical Products

Definition: The Transcutaneous Air Conduction Hearing Aid System Is A Wearable Sound-amplifying Device That Is Intended To Compensate For Impaired Hearing. It Consists Of An Air Conduction Hearing Aid Attached To A Surgically Fitted Tube System. The Tube Creates An Air Channel Through The Soft Tissue Between Outer Ear Canal And The Post-auricular Region Of The

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 874.3950

Radiation Type	Acoustic
Radition Safety	None
Annual Reports	No

Hearing Aid, Air Conduction, Transcutaneous System [32695]	21 CFR §874.3950 🔎
Hearing Aid, Air Conduction, Transcutaneous System [32308]	21 CFR §874.3950 🔎
Hearing Aid, Air Conduction, Transcutaneous System [31251]	21 CFR §874.3950 🔎
Hearing Aid, Air Conduction, Transcutaneous System [38689]	21 CFR §874.3950 🔎
Hearing Aid, Air Conduction, Transcutaneous System [32302]	21 CFR §874.3950 🔎
Hearing Aid, Air Conduction, Transcutaneous System [29591]	21 CFR §874.3950 🔎
Hearing Aid, Air Conduction, Transcutaneous System [33856]	21 CFR §874.3950 🔎
Hearing Aid, Air Conduction, Transcutaneous System [38629]	21 CFR §874.3950 🔎
Hearing Aid, Air Conduction, Transcutaneous System [32307]	21 CFR §874.3950 🔎

Hearing Aid, Air Conduction, Transcutaneous System

Product Code: NIX

Code of Federal Regulations: 874.3950

Products Classified as NIX

Total Product Life Cycle (TPLC) Devices

FDA Consensus Standards

Pre-market Notifications for NIX