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Introduction: The totally implantable active middle ear implant Esteem® may be considered an effective alternative to conventional hearing aids (cHAs) to manage moderate-to-severe forms of sensorineural hearing loss. This study aimed to provide long-term comparative data of Esteem performances with those achieved by cHA. Methods: From a total of 46 subjects who received unilateral application of Esteem®, and were followed up over the years, ten underwent an audiological assessment that compared the outcomes with those achieved in the contralateral ear by a cHA, considering the initially symmetric auditory thresholds in both ears. Other than pure tone audiometry and speech audiometry in quiet, the assessment was performed by using the adaptive speech in noise, i.e., Matrix test. Results: The mean speech intelligibility in quiet shows in the unaided situation a recognition of 50.7% at 71 dBHL, 71% at 69 dBHL with only contralateral cHA, 92% at 66 dBHL with only Esteem device and 94% at 61 dBHL with Esteem® device and contralateral cHA. The mean speech intelligibility in noise shows in the unaided situation a recognition of 36% at 71 dBHL, 56% at 69 dBHL with only contralateral cHA, 79% at 66 dBHL with only Esteem® device and 84% at 61 dBHL with Esteem® device and contralateral cHA. At Matrix test in the unaided condition, 4 patients reached 50% of intelligibility and the 50% threshold was obtained with a mean sound/noise ratio of +10 dBHL. In the contralaterally aided condition, 10 patients reached a 50% threshold in a condition of mean S/N ratio of +10.6 dBHL. In the Esteem® only and Esteem® plus cHA condition, all patients reached the 50% threshold with a mean S/N ratio of +3.4 dBHL with the Esteem® device and +0.92 dBHL with Esteem® plus a contralateral cHA, with a statistically nonsignificant difference. The mean deviation from the reference value (7.1 dB in the normal hearing population) was 17.1 dBHL, in unaided situation; this condition did not change with only the contralateral cHA (17.6 dBHL), whilst a significant improvement could be identified with only Esteem® device, where the mean deviation was 10.5 dBHL, and mostly with Esteem® device associated with the contralateral cHA, with a value of 8.02 dBHL. Conclusions: The adaptive speech audiometry in noise (Matrix Test) showed that binaural stimulation provides greater benefits in the speech recognition in noise test in comparison to monaural stimulation, especially when this is carried out only by the cHA. However, the Esteem® device allowed to obtain audiological benefits that are significantly superior to those offered by cHAs, especially in cases where the hearing loss is severe and, in some cases, profound, achieving performances almost comparable to those of a cochlear implant.
Introduction: The totally implantable active middle ear implant Esteem® may be considered an effective alternative to conventional hearing aids (cHAs) to manage moderate-to-severe forms of sensorineural hearing loss. This study aimed to provide long-term comparative data of Esteem performances with those achieved by cHA. Methods: From a total of 46 subjects who received unilateral application of Esteem®, and were followed up over the years, ten underwent an audiological assessment that compared the outcomes with those achieved in the contralateral ear by a cHA, considering the initially symmetric auditory thresholds in both ears. Other than pure tone audiometry and speech audiometry in quiet, the assessment was performed by using the adaptive speech in noise, i.e., Matrix test. Results: The mean speech intelligibility in quiet shows in the unaided situation a recognition of 50.7% at 71 dBHL, 71% at 69 dBHL with only contralateral cHA, 92% at 66 dBHL with only Esteem device and 94% at 61 dBHL with Esteem® device and contralateral cHA. The mean speech intelligibility in noise shows in the unaided situation a recognition of 36% at 71 dBHL, 56% at 69 dBHL with only contralateral cHA, 79% at 66 dBHL with only Esteem® device and 84% at 61 dBHL with Esteem® device and contralateral cHA. At Matrix test in the unaided condition, 4 patients reached 50% of intelligibility and the 50% threshold was obtained with a mean sound/noise ratio of +10 dBHL. In the contralaterally aided condition, 10 patients reached a 50% threshold in a condition of mean S/N ratio of +10.6 dBHL. In the Esteem® only and Esteem® plus cHA condition, all patients reached the 50% threshold with a mean S/N ratio of +3.4 dBHL with the Esteem® device and +0.92 dBHL with Esteem® plus a contralateral cHA, with a statistically nonsignificant difference. The mean deviation from the reference value (7.1 dB in the normal hearing population) was 17.1 dBHL, in unaided situation; this condition did not change with only the contralateral cHA (17.6 dBHL), whilst a significant improvement could be identified with only Esteem® device, where the mean deviation was 10.5 dBHL, and mostly with Esteem® device associated with the contralateral cHA, with a value of 8.02 dBHL. Conclusions: The adaptive speech audiometry in noise (Matrix Test) showed that binaural stimulation provides greater benefits in the speech recognition in noise test in comparison to monaural stimulation, especially when this is carried out only by the cHA. However, the Esteem® device allowed to obtain audiological benefits that are significantly superior to those offered by cHAs, especially in cases where the hearing loss is severe and, in some cases, profound, achieving performances almost comparable to those of a cochlear implant.
Summary Purpose The objective of this study was to assess and compare the long-term safety and subjective satisfaction levels of Bonebridge (BB) and Vibrant Soundbridge (VSB) in patients with congenital unilateral conductive hearing loss (UCHL). Methods The hearing effectiveness was measured using sound field hearing threshold (SFHT) and word recognition score (WRS). Long-term safety and subjective satisfaction levels were measured by questionnaires, including Speech, Spatial, and Qualities of Hearing Scale-12 (SSQ-12) and Abbreviated Profile of Hearing Aid Benefit (APHAB). Results Both BB and VSB were effective in improving the hearing of patients with congenital UCHL. Four of the 20 patients discontinued wearing the device postoperatively, and no complications were reported by long-term users. Patients experienced an overall improvement in their hearing experience across most subscales of SSQ-12 and a lower hearing problem rate across most subscales of the APHAB after implantation. However, the ‘quality of hearing’ subscale in the SSQ-12 did not show any improvement, and the aversiveness subscale in the APHAB exhibited a relatively higher percentage of reported problems after BB or VSB implantation. No significant differences were observed in SFHT, WRS, SSQ-12, and APHAB between the two groups. Conclusions Both BB and VSB are effective in improving the hearing of UCHL patients, with high subjective satisfaction and low complication rates in the long-term postoperative period, with no significant difference between the two devices. Follow-up device fitting is essential, especially to address increased device sound or noise after surgery, reduce non-usage rates and achieve higher subjective satisfaction levels.
This study delves into the intricate mechanics of human middle ear implants by examining a lumped parameter model with five degrees of freedom to estimate sound transfer. The ASTM standard, recognized globally as a benchmark, served as a reference for analysis, ensuring test accuracy and providing a comprehensive evaluation framework. To assess the implant’s usability, numerical simulations were conducted and compared against both the ASTM standard and the experimental results obtained from temporal bone studies. This investigation uncovered the bistability of periodic responses induced by the implant, prompting an analysis of the bistability in periodic solutions and the creation of basins of attraction for various initial conditions. The discovery of new solutions underscores this study’s significance in the operation and reliability of implants. Consequently, this research not only enhances the theoretical comprehension of the system, but also holds promise for practical applications in the design and optimization of middle ear implants that transfer energy to the stapes and the cochlea.
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