mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

The MED-EL PMEI Tympanoplasty Partial Prostheses are passive middle ear implants used to replace components of the ossicular chain in patients with congenital or acquired ossicular defects, or inadequate conductive hearing from previous surgery. The devices restore sound transmission from the tympanic membrane to the oval window by partially replacing the ossicles and are implanted by qualified ENT surgeons.

The devices are made of medical-grade titanium and come in four designs: mXACT (fixed length, snap-closing mechanism), mXACT PRO (length-adjustable via snap-mechanism, includes 5 sizers), mCLIP (clip-based coupling, optional bending), and mCLIP ARC (ball-joint headplate for adaptive movement). All are single-use, sterile, MRI conditional at 1.5T/3.0T/7.0T, with functional lengths ranging 0.75–3.50 mm and biocompatible per EN ISO 10993.

EN ISO 10993 (biocompatibility), EN ISO 11137-1/11137-2 (gamma sterilization), EN ISO 11607 (shelf-life and packaging validation), ASTM F2119/F2052/F2182 (MRI environment testing), mechanical and performance testing.

The MED-EL devices are substantially equivalent because they treat the same medical conditions, restore sound transmission via identical mechanical principles, use biocompatible titanium materials, achieve comparable audiological outcomes (72% of patients achieving postoperative air-bone gap ≤20 dB, matching state-of-the-art rates of 62.5–71.3%), and have similar safety profiles (low revision and dislocation rates) as the predicate devices. Although surgical tool designs differ slightly, this represents an improvement rather than a safety concern, as the mXACT PRO headplate closes with standard tweezers versus special surgical instruments required for the predicate TTP-VARIAC system.