Tympano-stapedotomy With a New Semisynthetic TORP: A Less Invasive Alternative to Malleo-stapedotomy

Area of Science:

• Otolaryngology
• Neurosurgery
• Medical Devices

Background:

• Otosclerosis with malleus fixation and incus necrosis present surgical challenges.
• Malleo-stapedotomy is a common but technically demanding procedure.
• Revision stapedotomy with unusable incus requires alternative reconstructive methods.

Purpose of the Study:

• To evaluate the initial clinical outcomes of tympano-stapedotomy utilizing a novel semisynthetic total ossicular replacement prosthesis (NSSTORP).
• To assess the efficacy of NSSTORP as a less invasive alternative to malleo-stapedotomy in primary and revision otologic surgery.
• To determine the safety and audiological benefits of this new surgical technique.

Main Methods:

• A prospective study involving 6 patients (3 primary, 3 revision) undergoing tympano-stapedotomy with NSSTORP implantation.
• Procedures were performed under local anesthesia with surgical microscopy.
• Pre- and postoperative audiometric evaluations assessed air conduction, bone conduction, and air-bone gap (ABG) at key frequencies.

Main Results:

• All patients achieved a postoperative ABG ≤20 dB, indicating successful hearing restoration.
• Mean air-bone gap improved by 14.1 dB, with a mean hearing gain of 16.8 dB.
• No adverse events such as worsening bone conduction, dizziness, or tinnitus were reported.

Conclusions:

• Tympano-stapedotomy with NSSTORP is a safe and effective procedure for selected cases of otosclerosis and revision stapedotomy.
• This technique simplifies the surgical process compared to malleo-stapedotomy.
• NSSTORP implantation effectively bridges the ossicular gap, avoiding vestibular penetration and improving hearing outcomes.