Cost Effectiveness of Cochlear Implantation in Single-Sided Deafness.

OBJECTIVE: To analyze the cost effectiveness of cochlear implantation (CI) for the treatment of single-sided deafness (SSD). STUDY DESIGN: Cost-utility analysis in an adapted Markov model. SETTING: Adults with single-sided deafness in a high-income country. INTERVENTION: Unilateral CI was compared with no intervention. MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratios were compared with different cost-effectiveness thresholds ($10,000 to $150,000) for different age, sex, and cost combinations. The calculations were based on the quality-adjusted life year (QALY), national life expectancy tables, and different cost settings. The health utility values for the QALY were either directly collected from published data, or, derived from published data using a regression model of multiple utility indices (regression estimate). RESULTS: The regression estimate showed an increase of the health utility value from 0.62 to 0.74 for SSD patients who underwent CI. CI for SSD was cost effective for women up to 64 years ($50,000 per-QALY threshold), 80 years ($100,000 per-QALY threshold), and 86 years ($150,000 per-QALY threshold). For men, these values were 58, 77, and 84, respectively. Changing the discount rate by up to 5% further increased the cutoff ages up to 5 years. A detailed cost and age sensitivity analysis is presented and allows testing for cost effectiveness in local settings worldwide. CONCLUSIONS: CI is a cost-effective option to treat patients with SSD.

Assessment of Surgical Complications With Respect to the Surgical Indication: Proposal for a Novel Index.

Introduction: The Clavien-Dindo classification is a broadly accepted surgical complications classification system, grading complications by the extent of therapy necessary to resolve them. A drawback of the method is that it does not consider why the patient was operated on primarily. Methods: We designed a novel index based on Clavien-Dindo but with respect to the surgical indication. We surveyed an international panel of otolaryngologists who filled out a questionnaire with 32 real case-inspired scenarios. Each case was graded for the surgical complication, surgical indication, and a subjective rating whether the complication was acceptable or not. Results: Seventy-seven otolaryngologists responded to the survey. Mean subjective rating and surgical complication grading for each scenario showed an inverse correlation (r 2 = 0.147, p = 0.044). When grading the surgical complication with respect to the surgical indication, the correlation with the subjective rating increased dramatically (r 2 = 0.307, p = 0.0022). Conclusion: We describe a novel index grading surgical complications with respect to the surgical indication. In our survey, most respondents judged a complication as acceptable or not according to its grade but kept in mind the surgical indication. This subjective judgment could be quantified with our novel index.

Age Dependent Cost-Effectiveness of Cochlear Implantation in Adults. Is There an Age Related Cut-off?

OBJECTIVE: To analyze the impact of age at implantation on the cost-effectiveness of cochlear implantation (CI). STUDY DESIGN: Cost-utility analysis in an adapted Markov model. SETTING: Adults with profound postlingual hearing loss in a "high income" country. INTERVENTION: Unilateral and sequential CI were compared with hearing aids (HA). MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratio (ICER), calculated as costs per quality adjusted life year (QALY) gained (in CHF/QALY), for individual age and sex combinations in relation to two different willingness to pay thresholds. 1 CHF (Swiss franc) is equivalent to 1.01 USD. RESULTS: When a threshold of 50,000 CHF per QALY is applied, unilateral CI in comparison to HA is cost-effective up to an age of 91 for women and 89 for men. Sequential CI in comparison to HA is cost-effective up to an age of 87 for women and 85 for men. If a more contemporary threshold of 100,000 CHF per QALY is applied, sequential CI in comparison to unilateral CI is cost-effective up to an age of 80 for women and 78 for men. CONCLUSIONS: Performing both sequential and unilateral CI is cost-effective up to very advanced ages when compared with hearing aids.

In-vivo assessment of osseous versus non-osseous transmission pathways of vibratory stimuli applied to the bone and the dura in humans.

BACKGROUND: Bone conduction (BC) is an alternative to air conduction (AC) for stimulation of the inner ear. Stimulation for BC can occur directly on the skull bone, on the skin covering the skull bone, or on soft tissue (i.e., eye, dura). All of these stimuli can elicit otoacoustic emissions (OAE). This study aims to compare OAEs generated by different combinations of stimuli in live humans, including direct stimulation of the intracranial contents via the dura, measured intraoperatively. METHODS: Measurements were performed in five normal-hearing ears of subjects undergoing a neurosurgical intervention with craniotomy in general anesthesia. Distortion product OAEs (DPOAEs) were measured for f2 at 0.7, 1, 2, 3, 4, and 6 kHz with a constant ratio of the primary frequencies (f2/f1) of 1.22. Sound pressure L1 was held constant at 65 dB SPL, while L2 was decreased in 10 dB steps from 70 to 30 dB SPL. A DPOAE was considered significant when its level was ≥6 dB above the noise floor. Emissions were generated sequentially with different modes of stimulation: 1) pre-operatively in the awake subject by two air-conducted tones (AC-AC); 2) within the same session preoperatively by one air- and one bone-conducted tone on the skin-covered temporal bone as in audiometry (AC-BC); 3) intra-operatively by one air-conducted tone and one bone-vibrator tone applied directly on the dura (AC-DC). A modified bone vibrator (Bonebridge; MED-EL, Innsbruck, Austria) was used for BC stimulation on the dura or skin-covered mastoid. Its equivalent perceived SPL was calibrated preoperatively for each individual by psychoacoustically comparing the level of a BC tone presented to the temporal region to an AC tone at the same frequency. Simultaneously with the DPOAEs, vibrations at the teeth were measured with an accelerometer attached using a custom-made holder. RESULTS: It was possible to record DPOAEs for all three stimulation modes. For AC-DC, DPOAEs were not detected above the noise floor below 2 kHz but were detectable at the higher frequencies. The best response was measured at or above 2 kHz with L2 = 60 dB SPL. The acceleration measured at the teeth for stimulation on the dura was lower than that for stimulation on the bone, especially below 3 kHz. CONCLUSION: We demonstrate a proof-of-concept comparison of DPOAEs and teeth acceleration levels elicited by a bone vibrator placed either against the skin-covered temporal bone, as in audiometry, or directly against the dura mater in patients undergoing a craniotomy. It was demonstrated that DPOAEs could be elicited via non-osseous pathways within the skull contents and that the required measurements could be performed intra-operatively.

Assessment of Cochlear Function during Cochlear Implantation by Extra- and Intracochlear Electrocochleography.

Objective: The aims of this study were: (1) To investigate the correlation between electrophysiological changes during cochlear implantation and postoperative hearing loss, and (2) to detect the time points that electrophysiological changes occur during cochlear implantation. Material and Methods: Extra- and intracochlear electrocochleography (ECoG) were used to detect electrophysiological changes during cochlear implantation. Extracochlear ECoG recordings were conducted through a needle electrode placed on the promontory; for intracochlear ECoG recordings, the most apical contact of the cochlear implant (CI) electrode itself was used as the recording electrode. Tone bursts at 250, 500, 750, and 1000 Hz were used as low-frequency acoustic stimuli and clicks as high-frequency acoustic stimuli. Changes of extracochlear ECoG recordings after full insertion of the CI electrode were correlated with pure-tone audiometric findings 4 weeks after surgery. Results: Changes in extracochlear ECoG recordings correlated with postoperative hearing change (r = -0.44, p = 0.055, n = 20). Mean hearing loss in subjects without decrease or loss of extracochlear ECoG signals was 12 dB, compared to a mean hearing loss of 22 dB in subjects with a detectable decrease or a loss of ECoG signals (p = 0.0058, n = 51). In extracochlear ECoG recordings, a mean increase of the ECoG signal of 4.4 dB occurred after opening the cochlea. If a decrease of ECoG signals occurred during insertion of the CI electrode, the decrease was detectable during the second half of the insertion. Conclusion: ECoG recordings allow detection of electrophysiological changes in the cochlea during cochlear implantation. Decrease of extracochlear ECoG recordings during surgery has a significant correlation with hearing loss 4 weeks after surgery. Trauma to cochlear structures seems to occur during the final phase of the CI electrode insertion. Baseline recordings for extracochlear ECoG recordings should be conducted after opening the cochlea. ECoG responses can be recorded from an intracochlear site using the CI electrode as recording electrode. This technique may prove useful for monitoring cochlear trauma intraoperatively in the future.

Assessment of Cochlear Trauma During Cochlear Implantation Using Electrocochleography and Cone Beam Computed Tomography.

OBJECTIVE: To assess cochlear trauma during cochlear implantation by electrocochleography (ECoG) and cone beam computed tomography (CBCT) and to correlate intraoperative cochlear trauma with postoperative loss of residual hearing. METHODS: ECoG recordings to tone bursts at 250, 500, 750, and 1000 Hz and click stimuli were recorded before and after insertion of the cochlear implant electrode array, using an extracochlear recording electrode. CBCTs were conducted within 6 weeks after surgery. Changes of intraoperative ECoG recordings and CBCT findings were correlated with postoperative threshold shifts in pure-tone audiograms. RESULTS: Fourteen subjects were included. In three subjects a decrease of low-frequency ECoG responses at 250, 500, 750, and 1000 Hz occurred after insertion of the electrode array. This was associated with no or minimal residual hearing 4 weeks after surgery. ECoG responses to click stimuli were present in six subjects and showed a decrease after insertion of the electrode array in three. This was associated with a mean hearing loss of 21 dB in postoperative pure-tone audiograms. Scalar dislocation of the electrode array was assumed in one subject because of CBCT findings and correlated with a decrease of low-frequency ECoG responses and a complete loss of residual hearing. CONCLUSION: Hearing loss of ≤11 dB is not associated with detectable decrease in ECoG recordings during cochlear implantation. However, in a majority of patients with threshold shifts of >11 dB or complete hearing loss, an intraoperative decrease of high- or low-frequency ECoG signals occurs, suggesting acute cochlear trauma.

Mechanical and biochemical mapping of human auricular cartilage for reliable assessment of tissue-engineered constructs.

It is key for successful auricular (AUR) cartilage tissue-engineering (TE) to ensure that the engineered cartilage mimics the mechanics of the native tissue. This study provides a spatial map of the mechanical and biochemical properties of human auricular cartilage, thus establishing a benchmark for the evaluation of functional competency in AUR cartilage TE. Stress-relaxation indentation (instantaneous modulus, Ein; maximum stress, σmax; equilibrium modulus, Eeq; relaxation half-life time, t1/2; thickness, h) and biochemical parameters (content of DNA; sulfated-glycosaminoglycan, sGAG; hydroxyproline, HYP; elastin, ELN) of fresh human AUR cartilage were evaluated. Samples were categorized into age groups and according to their harvesting region in the human auricle (for AUR cartilage only). AUR cartilage displayed significantly lower Ein, σmax, Eeq, sGAG content; and significantly higher t1/2, and DNA content than NAS cartilage. Large amounts of ELN were measured in AUR cartilage (>15% ELN content per sample wet mass). No effect of gender was observed for either auricular or nasoseptal samples. For auricular samples, significant differences between age groups for h, sGAG and HYP, and significant regional variations for Ein, σmax, Eeq, t1/2, h, DNA and sGAG were measured. However, only low correlations between mechanical and biochemical parameters were seen (R<0.44). In conclusion, this study established the first comprehensive mechanical and biochemical map of human auricular cartilage. Regional variations in mechanical and biochemical properties were demonstrated in the auricle. This finding highlights the importance of focusing future research on efforts to produce cartilage grafts with spatially tunable mechanics.

Objective assessment of stapedotomy surgery from round window motion measurement.

OBJECTIVES: As prostheses and techniques related to stapes surgery develop and improve, there is a need to assess the functional outcomes of the surgery objectively. This study provides a bench test method to assess the functional results of stapes surgery by measuring volume displacement at the round window (RW), which is closely related to pressure propagation of the travelling wave inside the cochlea and thus to hearing. DESIGN: Motion of the RW membrane in fresh temporal bones was measured using a scanning laser Doppler interferometry system for normal and reconstructed conditions, and the performance of the reconstruction with stapes surgery was quantitatively assessed by comparison of the volume displacements at the RW between the two conditions. To obtain optimal measurements, reflectivity of the laser beam of the scanning laser Doppler interferometry system was improved by retroreflective beads coated onto the surface of the RW, and orientation of the RW membrane relative to the laser beam was obtained using micro-computed tomography imaging. RESULTS: From measurements in 12 temporal bones, difference in the RW volume displacement between normal ears and ears reconstructed with stapes surgery was approximately 15 dB below 2 kHz and approximately 10 dB above 4 kHz, which was comparable with air-bone gaps in patients after stapes surgery. Two different sizes of the stapes prostheses were also tested (n = 3), and a tendency toward a better outcome with a larger diameter was found. CONCLUSION: The method developed in this study can be used to assess various prostheses and surgical conditions objectively in controlled laboratory environments. It may also have potential for providing ways to assess other middle- and inner-ear surgeries, and to study other aspects of hearing science.