Comparison of hearing results of nitinol SMART stapes piston prosthesis with conventional piston prostheses: postoperative results of nitinol stapes prosthesis.

OBJECTIVE

Recently, a new stapedotomy piston prosthesis, which is a composite metal alloy of nickel and titanium known as nitinol, has been introduced into medical use. This biocompatible alloy has the unique property of shape-memory, which permits tight self-crimping when heat is applied to the wire. To substantiate the favorable initial observations with the SMART piston, this study was undertaken to compare these results (n=26) with those obtained using conventional stainless steel or platinum ribbon prostheses (n=28).

STUDY DESIGN

Prospective consecutive case review: consecutive cases performed by the same surgeon were analyzed.

SETTING

Tertiary referral center.

PATIENTS

Fifty-four healthy patients with otosclerosis.

INTERVENTION

Stapedotomy using either SMART prosthesis or conventional prosthesis.

MAIN OUTCOME MEASURES

Hearing outcomes by audiological assessment.

RESULTS

The postoperative hearing mean pure-tone average was 24.81+/-16.20 dBHL for Group 1 (SMART prosthesis) and 27.46+/-15.57 dBHL for Group 2 (conventional prosthesis). Postoperative mean air-bone gap was 7.07+/-8.14 dBHL for Group 1 and 6.38+/-7.54 dBHL for Group 2 using 0.5-, 1-, 2-, and 4-kHz frequencies. When analyzed according to the American Academy of Otolaryngology-Head & Neck Surgery reporting criteria using an estimate of 3 kHz as a mean of the 2-and 4-kHz values, the postoperative mean air-bone gap was 5.42+/-5.4 dBHL for Group 1 SMART and 5.98+/-5.47 dBHL for Group 2 conventional prostheses. Postoperative speech discrimination scores were 96%+/-8.64% and 97%+/-5.9%, respectively. These differences were not shown to be statistically different.

CONCLUSION

Results demonstrate that experienced surgeons may achieve comparable results with both prostheses; however, the ease of self-crimping and the tightness of the crimp may provide advantages that may have long-term benefits. The potential issue of nickel allergy is important when considering patients for this prosthesis.