Functional Results and Subjective Benefit of a Transcutaneous Bone Conduction Device in Patients With Single-Sided Deafness.

OBJECTIVE: To analyze speech discrimination scores and subjective benefit of a transcutaneous bone conduction device (tBCD) in adults with single-sided deafness (SSD). STUDY DESIGN: Prospective cohort study. SETTING: Tertiary referral center. PATIENTS: Nine adults with SSD for more than 1 year and normal hearing on the contralateral side (PTA <30 dB HL) were implanted with a tBCD. INTERVENTIONS: Transmastoidal implantation of a Bonebridge (BB, MED-EL) tBCD. MAIN OUTCOME MEASURES: Aided and unaided speech discrimination scores in three different spatial settings were measured using the Oldenburg sentence test (OLSA). Quality of life was assessed by two questionnaires, the Bern Benefit in Single Sided Deafness Questionnaire (BBSS) and the Speech, Spatial and Qualities of Hearing scale for benefit questionnaire (SSQ-B). RESULTS: Speech discrimination scores measured by OLSA showed a mean signal-to-noise ratio improvement of 1.7 dB SPL for the aided condition compared with the unaided condition in the setting where the sound signal is presented on the side of the implanted ear and the noise is coming from the front (p < 0.05). In the other two settings (signal and noise from front; signal from normal hearing ear and noise from front), the signal-to-noise ratio did not change significantly. This benefit became manifest after 6 months. Good satisfaction was indicated by positive results on the questionnaires. CONCLUSION: Speech discrimination in noise for patients implanted with the BB is comparable with patients with other bone conduction hearing aids. A learning curve is clearly detectable. The subjective benefit was rated positively by the patients. With the advantage of intact skin conditions after implantation, the BB is an adequate option for patients with SSD.

How does closure of tympanic membrane perforations affect hearing and middle ear mechanics? An evaluation in a patient cohort and temporal bone models.

OBJECTIVE: This study aimed to determine how tympanic membrane (TM) perforations and their closure, using a paper-patch technique, affect middle-ear mechanics and, thus, conductive hearing for different sizes of the TM perforation. STUDY DESIGN: Temporal bone (TB) study and prospective clinical trial. SETTING: Tertiary referral center. PATIENTS: Nine patients with chronic otitis media for more than 3 months. INTERVENTION: The TM perforations were closed with a paper patch in all 9 patients. In 5 of 9 patients, myringoplasty was performed. Matching TM perforations were created in a TB model (n = 8) and closed using the paper patch. MAIN OUTCOME MEASURES: Air-bone gap was measured in all 9 patients of the patient cohort with TM perforations before and after closure and in 5 patients after myringoplasty. Stapes velocity and sound pressure difference between the ear canal and middle-ear cavity were measured in TBs with intact TM, with TM perforations, and with the perforations closed by the paper patch. All measurements in the patient cohort and TBs were performed for different sizes of TM perforations to determine if the effects varied as a function of size. RESULTS: Degree of the air-bone gap differed as a function of size of the TM perforations and its recovery after closure, and myringoplasty was independent of the size of the TM perforation in the frequency range of 0.25 to 4 kHz. In the TB measurements, although pressure difference across the TM was almost fully recovered by closing the perforation with a paper patch, recovery of the stapes motion was limited at frequencies above 4.5 kHz for larger sizes of TM perforations. CONCLUSION: Hearing loss caused by TM perforations depends on the size of the perforation. Hearing returns almost completely across the frequency range after closure except above 4 kHz for larger perforations. This is because the structural damage caused by large TM perforations cannot be completely restored by application of a paper patch.

The impact of platelet-derived growth factor on closure of chronic tympanic membrane perforations: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: Patients with tympanic membrane (TM) perforations often have infections, and repetitive topical treatment may be required. These infections can be prevented by permanent closure of the TM perforation. Different surgical treatment options have been described, but noninvasive techniques may be preferred as they carry less risk than surgery. One noninvasive approach is to induce wound healing by application of growth factors. The effect and clinical use of applying topical platelet-derived growth factor (PDGF) for decrease of size and closure of chronic TM perforations is evaluated. STUDY DESIGN: Prospective, randomized, placebo-controlled, double-blind study. SETTING: Tertiary referral center. PATIENTS: Twenty patients with chronic suppurative otitis media without cholesteatoma for more than 3 months. INTERVENTION: Topical treatment with PDGF or placebo applied weekly to the TM for 6 weeks. MAIN OUTCOME MEASURES: Success rate, defined as a reduction of perforation size of 50% or more to determine relative changes of the perforation size; effect of initial size and location of TM perforation on success rate; and air and bone conduction thresholds to determine air-bone gap measured before treatment. RESULTS: Randomization made matching pretreatment perforation size of the 2 study groups impossible, and the initial rate perforation/TM was significantly smaller in the PDGF group. No difference between the 2 groups was found for perforation/TM less than 10%. However, success rate did not differ significantly between the 2 groups (power = 0.8), and the effect of PDGF was found to be small (-2%; standard deviation, ±49%). Initial size and position of the TM perforation were not significant factors determining success. Mean air-bone gap for the frequencies of 0.5, 1, 2, and 4 kHz was 22.5 dB. CONCLUSION: The topical application of PDGF as an office treatment for chronic otitis media is not a favorable alternative to surgery.

Biocompatibility of nitinol stapes prosthesis.

OBJECTIVE: Use of the SMart piston, a nitinol-based, self-crimping prosthesis in stapes surgery may allow improved functional results because of better sound transmission properties at the incus-prosthesis interface because of the elimination of manual crimping. Possible disadvantages include thermal damage or strangulation of the incus and its mucoperiosteum or nickel intolerance. The goal of this study was to morphologically assess the fixation of this prosthesis to the incus, investigate the reaction of the middle ear mucosa to the prosthesis, identify alterations to the incudal bone, and detect deposits of nickel in the tissue around the prosthesis. STUDY DESIGN: Prospective consecutive case analysis. SETTING: Tertiary referral center. PATIENTS: Four patients with an unfavorable functional result after primary SMart-piston stapedotomy. INTERVENTION: Revision malleostapedotomy with explantation of the incus and prosthesis for further analysis. MAIN OUTCOME MEASURES: Analysis of intraoperative findings and postoperative examination of the explants using light- and scanning-electron microscopy, energy dispersive x-ray analysis, and atom absorption spectrometry. RESULTS: The intraoperative, macroscopic, and scanning electron microscopic investigation showed tight circular fixation of the prostheses, whereas a gap between the prosthesis and the lateral incus was found in 1 case. All prostheses were overgrown by mucosa. Superficial localized erosion of the incudal bone was found in 2 cases. There was no elevation in nickel content in the removed tissue samples. CONCLUSION: The lateral gap between prosthesis and incus did not affect fixation of the prosthesis, neither did covering by a mucosal layer. Bone erosion was most likely caused by laser in one and by the prosthesis in another explant. No signs of increased nickel deposits could be found on energy dispersive x-ray analysis or atom absorption spectrometry. We conclude that a nitinol stapes prosthesis is safe for treatment of stapedial fixation.

The incudo-malleolar joint and sound transmission losses.

The question as to whether the incudo-malleolar joint (IMJ) is mobile or immobile at moderate sound pressure levels (SPLs) is addressed. Referring to the mechanical properties of elastic tissue, we suggest that the IMJ is mobile at any SPL. In order to test this hypothesis, we investigated the dynamics of the IMJ in nine temporal bones by means of laser scanning doppler vibrometry. The dynamic behavior of both ossicles, malleus and incus is described by three degrees of freedom, and transfer functions (TFs) are shown for each motion component [corrected]. We show that there is indeed relative motion between the malleus and the incus. This transmission loss affects the middle ear TF and results in a frequency dependent sound transmission loss. Some characteristics of our results are in agreement with middle ear TFs described in the literature. The increasing transmission loss towards higher frequencies is caused by relative motion between malleus and incus at the IMJ. The concept that the IMJ is functionally mobile is consistent with the physical properties of elastic tissues which most likely define the mechanics of this joint. Since the IMJ is indeed mobile at moderate sound intensities and audible frequencies the theory of the lever ratio being responsible for the characteristics of the middle ear TF must be reconsidered.