title: Comparison of hearing results of nitinol SMART stapes piston prosthesis with conventional piston prostheses: postoperative results of nitinol stapes prosthesis.
abstract: 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).
  
  
  METHODS
  Prospective consecutive case review: consecutive cases performed by the same surgeon were analyzed.
  
  
  METHODS
  Tertiary referral center.
  
  
  METHODS
  Fifty-four healthy patients with otosclerosis.
  
  
  METHODS
  Stapedotomy using either SMART prosthesis or conventional prosthesis.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Otolaryngology-Head & Neck Surgery, University of California, San Diego 92103-8895, USA, and Union Hospital, Wuhan, China. jpharris@ucsd.edu
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Harris
authors.forename: Shusheng
authors.initials: S
authors.lastname: Gong
mesh_terms: D000328:Adult; D000368:Aged; D000497:Alloys; D001301:Audiometry, Pure-Tone; D003054:Cochlear Implants; D016057:Evoked Potentials, Auditory, Brain Stem / Q000502:physiology; D005260:Female; D006319:Hearing Loss, Sensorineural / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010040:Otosclerosis / Q000150:complications / Q000601:surgery*; D011182:Postoperative Care; D011446:Prospective Studies; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000295:instrumentation; D012720:Severity of Illness Index; D013201:Stapes Surgery; D015607:Stents
chemical_list: D000497:Alloys; C013616:nitinol