title: Malleus-to-footplate versus malleus-to-stapes-head ossicular reconstruction prostheses: temporal bone pressure gain measurements and clinical audiological data.
abstract: OBJECTIVE
  Several clinical reports suggest that if the stapes superstructure is intact, ossicular reconstruction should be made to the stapes head rather than the footplate to achieve a better hearing outcome. To test this hypothesis, we compared the in situ mechanical performance of hydroxylapatite (HA) malleus-to-stapes-head (MSH) ossicular reconstruction prosthesis (ORP) with malleus-to-footplate (MFP) ORP, both manufactured by Project HEAR.
  
  
  BACKGROUND
  ORPs are commonly used to replace a missing or deficient incus. However, hearing outcomes are highly variable, depending on the ORP material, design, surgical technique, and ORP positioning.
  
  
  METHODS
  Cochleo-vestibular pressure measurements in human cadaveric temporal bones for the HA MFP ORP have been reported by Puria et al. (2005). In the present study, the ear canal pressure Pe and cochleovestibular pressure Pv were measured in cadaveric temporal bones with intact incus, removed incus, and MSH ORP reconstruction. The relative loss in gain, Lmsh, is defined as the ratio of Pv with reconstructed MSH ORP to intact incus and compared with Lmfp. A retrospective clinical audit of the pre- and postoperative audiologic results of patients who had undergone ossiculoplasty with either MSH or MFP ORP was conducted for comparison.
  
  
  RESULTS
  For the 0.5 to 3 kHz frequency range, Lmsh magnitude is 6.2 dB lower than the Lmfp magnitude (p = 0.05). The retrospective audit of audiologic results after ossiculoplasty with either MSH or MFP ORP revealed a similar difference in gain between the two ORP designs with air-bone gap differences of 7.6 dB (p = 0.04) and air conduction threshold differences of 8.0 dB (p = 0.13) for these patients.
  
  
  CONCLUSIONS
  The MFP ORP showed better average pressure gain compared with the MSH ORP across the speech frequencies. Surgeons performing ossiculoplasty with designs similar to Project HEAR HA ORPs, where there is direct columella-like connection between the malleus and stapes, should consider using the MFP ORP design to achieve a better postoperative audiologic result, even when the stapes superstructure is intact.
authors: Stanford University, Department of Mechanical Engineering, Mechanics and Computation Division, Palo Alto, California, USA.
authors: Euan
authors: E
authors: Murugasu
authors: Sunil
authors: S
authors: Puria
authors: Joseph B
authors: JB
authors: Roberson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016477:Artifacts; D001298:Audiology; D004432:Ear, Middle / Q000503:physiopathology; D004867:Equipment Design; D006801:Humans; D007188:Incus; D008297:Male; D008307:Malleus; D008875:Middle Aged; D009998:Ossicular Prosthesis; D011312:Pressure; D012189:Retrospective Studies; D013199:Stapes; D013701:Temporal Bone / Q000503:physiopathology*