Ossiculoplasty with polymaleinate ionomeric prosthesis.
With the continued concern over the possible transmission of viral infections through homologous middle ear implants, there is increasing pressure to develop a truly biocompatible alloplastic middle ear prosthesis. The polymaleinate ionomer, which has been used in dentistry as a filling and luting material for more than 15 years, has recently been used to construct total and partial ossicular replacement prostheses. In an attempt to evaluate these new implants, a multicenter prospective clinical trial was initiated. To date, 92 patients have undergone implantation. The follow-up interval ranged from 3 months to 22 months. Although it is premature to discuss the long-term results, the preliminary surgical experience and audiometric data with these implants are reviewed. From a surgical perspective, the ionomeric prostheses were easily contoured with a diamond burr and were not prone to shattering. Preliminary follow-up audiometric data were available on 80 patients (59 partial ossicular replacement prostheses and 21 total ossicular replacement prostheses). Of the 59 partial ossicular replacement prostheses the air-bone gaps (average of 500 Hz, 1 kHz, 2 kHz and 3 kHz) were as follows: 0 dB to 10 dB, 15 (25%) of 59; 11 dB to 20 dB, 20 (34%) of 59; 21 dB to 30 dB, 11 (19%) of 59; and greater than 30 dB, 13 (22%) of 59. Of the 21 total ossicular replacement prostheses the air-bone gaps were as follows: 0 dB to 10 dB, 6 (29%) of 21; 11 dB to 20 dB, 6 (29%) of 21; 21 dB to 30 dB, 5 (24%) of 21; and greater than 30 dB, 4 (19%) of 21.
McElveen
J T
JT
Carolina Ear & Hearing Clinic, Raleigh, NC 27609, USA.
Feghali
J G
JG
Barrs
D M
DM
Shelton
C
C
Green
J D
JD
Horn
K L
KL
McKenna
M J
MJ
Thedinger
B S
BS
Wilson
D F
DF
Chen
D A
DA
D000161:Acoustic Stimulation; D000538:Aluminum Silicates / Q000138:chemical synthesis / Q000737:chemistry; D001299:Audiometry; D001672:Biocompatible Materials / Q000138:chemical synthesis / Q000737:chemistry; D001844:Bone Conduction; D004301:Doppler Effect; D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D005899:Glass Ionomer Cements / Q000138:chemical synthesis / Q000737:chemistry; D006309:Hearing; D006801:Humans; D007834:Lasers; D009998:Ossicular Prosthesis / Q000009:adverse effects; D011183:Postoperative Complications; D011446:Prospective Studies; D011474:Prosthesis Design; D013199:Stapes / Q000502:physiology; D013499:Surface Properties; D014432:Tympanic Membrane / Q000502:physiology; D014732:Vibration
D000538:Aluminum Silicates; D001672:Biocompatible Materials; D005899:Glass Ionomer Cements; C088058:polymaleinate ionomer