U.S. Phase I Preliminary Results of Use of the Otologics MET Fully-Implantable Ossicular Stimulator

2007 ◽  
Vol 137 (2) ◽  
pp. 206-212 ◽  
Author(s):  
Herman A. Jenkins ◽  
James S. Atkins ◽  
Drew Horlbeck ◽  
Michael E. Hoffer ◽  
Ben Balough ◽  
...  

OBJECTIVES: The safety of the Otologics Fully-Implantable MET Ossicular Stimulator was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss. METHODS: Surgical implantation of the ossicular stimulator was performed. A repeated-measure, within-subjects design assessed safety and aided sound field thresholds and speech performances with the subject's own, appropriately fitted, walk-in hearing aid(s) and the Otologics Fully-Implantable MET Ossicular Stimulator. RESULTS: Twenty patients were implanted and activated as part of the Phase I clinical trial. Results demonstrated 10–20 dB of functional gain across audiometric frequencies. Pure tone averages and monaural word recognition scores were slightly better for the walk-in—aided condition, while patient benefit scales favored the postoperative implant-aided conditions. CONCLUSION/SIGNIFICANCE: Although monaural word scores and aided thresholds favored the walk-in—aided condition, preliminary results indicate that the Otologics MET Fully-Implantable Ossicular Stimulator is an alternative to currently available hearing aids in patients with sensorineural hearing loss.

2008 ◽  
Vol 139 (2_suppl) ◽  
pp. P57-P57
Author(s):  
Drew M Horlbeck ◽  
Herman A Jenkins ◽  
Ben J Balough ◽  
Michael E Hoffer

Objective The efficacy of the Otologics Fully Implantable Hearing Device (MET) was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss. Methods Surgical insertion of this totally implanted system was identical to the Phase I study. A repeated-measures within-subjects design assessed aided sound field thresholds and speech performances with the subject's own, appropriately fit, walk-in hearing aid(s) and the Otologics Fully Implantable Hearing Device. Results Six- and 12-month Phase II data will be presented. Ten patients were implanted and activated as part Phase II clinical trial. Three patients were lost to long term follow-up due to two coil failures and one ossicular abnormality preventing proper device placement. No significant differences between preoperative (AC = 59 dB, BC = 55 dB) and postoperative (AC = 61 dB, BC = 54 dB) unaided pure tone averages were noted (p < 0.05). Pure tone average implant aided thresholds (41 dB) were equivalent to that of walk-in-aided (37 dB) condition with no significant difference (p < 0.05) between patients’ walk-in-aided individual frequency thresholds and implant-aided thresholds. Word recognition scores and hearing in noise scores were similar between the walk-in-aided and for the implant-aided condition. Patient benefit scales will be presented at all end points. Conclusions Results of the Otologics MET Fully Implantable Hearing Device Phase II trial provide evidence that this fully implantable device is a viable alternative to currently available hearing aids in patients with sensorineural hearing loss.


2021 ◽  
Vol 6 (3) ◽  
pp. 21-24
Author(s):  
Evgeniya R. Tsygankova ◽  
Vladimir E. Gaufman ◽  
Irina E. Grebenyuk ◽  
Elena E. Saveleva ◽  
Evgenii S. Savelev

Objectives to improve the quality of hearing aids (HA) selection for patients with sensorineural hearing loss using a comparative free sound field speech audiometry according to our modified method "Delta Test". Material and methods. The study involved 56 patients aged from 18 to 62 years with bilateral chronic sensorineural hearing loss of 2-4 degrees. The study group included 32 patients, a test for speech recognition in a free sound field (speech audiometry) was conducted using the method proposed by us. The control group consisted of 24 patients who were aided without the use of comparative speech audiometry. The "Delta Test" included the use of audio files sets containing a speech material in pure form and mixed with speech noise with different signal-to-noise ratios, supplied through a speaker system connected to a personal computer. The percentage of correctly repeated words was measured without HA and with several HA having different settings. The effectiveness of using HA was defined as the difference in the percentage of speech recognition when using HA in relation to the "ear without HA". Results. According to "The International Outcome Inventory for Hearing Aids" the average score was 4.13 0.10 in the group where the HA were selected using the "Delta Test", which is statistically significantly higher than in the control group, where the average score was 3.720.15(p 0.05). "Delta Test" allows optimally select the HA parameters. This method is easy to perform and does not require expensive equipment.


2017 ◽  
Author(s):  
Joanna Nkyekyer ◽  
Denny Meyer ◽  
Peter J Blamey ◽  
Andrew Pipingas ◽  
Sunil Bhar

BACKGROUND Sensorineural hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression, and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. Hearing aids have been proven as successful interventions to alleviate sensorineural hearing loss. In addition to hearing aid use, the positive effects of auditory training—formal listening activities designed to optimize speech perception—are now being documented among adults with hearing loss who use hearing aids, especially new hearing aid users. Auditory training has also been shown to produce prolonged cognitive performance improvements. However, there is still little evidence to support the benefits of simultaneous hearing aid use and individualized face-to-face auditory training on cognitive performance in adults with hearing loss. OBJECTIVE This study will investigate whether using hearing aids for the first time will improve the impact of individualized face-to-face auditory training on cognition, depression, and social interaction for adults with sensorineural hearing loss. The rationale for this study is based on the hypothesis that, in adults with sensorineural hearing loss, using hearing aids for the first time in combination with individualized face-to-face auditory training will be more effective for improving cognition, depressive symptoms, and social interaction rather than auditory training on its own. METHODS This is a crossover trial targeting 40 men and women between 50 and 90 years of age with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will be recruited from either an independent living accommodation or via a community database to undergo a 6-month intensive face-to-face auditory training program (active control). Participants will be assigned in random order to receive hearing aid (intervention) for either the first 3 or last 3 months of the 6-month auditory training program. Each participant will be tested at baseline, 3, and 6 months using a neuropsychological battery of computer-based cognitive assessments, together with a depression symptom instrument and a social interaction measure. The primary outcome will be cognitive performance with regard to spatial working memory. Secondary outcome measures include other cognition performance measures, depressive symptoms, social interaction, and hearing satisfaction. RESULTS Data analysis is currently under way and the first results are expected to be submitted for publication in June 2018. CONCLUSIONS Results from the study will inform strategies for aural rehabilitation, hearing aid delivery, and future hearing loss intervention trials. CLINICALTRIAL ClinicalTrials.gov NCT03112850; https://clinicaltrials.gov/ct2/show/NCT03112850 (Archived by WebCite at http://www.webcitation.org/6xz12fD0B).


2020 ◽  
Vol 5 (1) ◽  
pp. 36-39
Author(s):  
Mariya Yu. Boboshko ◽  
Irina P. Berdnikova ◽  
Natalya V. Maltzeva

Objectives -to determine the normative data of sentence speech intelligibility in a free sound field and to estimate the applicability of the Russian Matrix Sentence test (RuMatrix) for assessment of the hearing aid fitting benefit. Material and methods. 10 people with normal hearing and 28 users of hearing aids with moderate to severe sensorineural hearing loss were involved in the study. RuMatrix test both in quiet and in noise was performed in a free sound field. All patients filled in the COSI questionnaire. Results. The hearing impaired patients were divided into two subgroups: the 1st with high and the 2nd with low hearing aid benefit, according to the COSI questionnaire. In the 1st subgroup, the threshold for the sentence intelligibility in quiet was 34.9 ± 6.4 dB SPL, and in noise -3.3 ± 1.4 dB SNR, in the 2nd subgroup 41.7 ± 11.5 dB SPL and 0.15 ± 3.45 dB SNR, respectively. The significant difference between the data of both subgroups and the norm was registered (p


2017 ◽  
Vol 28 (10) ◽  
pp. 941-949 ◽  
Author(s):  
Charles E. Bishop ◽  
Elgenaid Hamadain ◽  
Jason A. Galster ◽  
Mary Frances Johnson ◽  
Christopher Spankovich ◽  
...  

Background: Unilateral sensorineural hearing loss (USNHL) can have a negative impact on functions associated with the advantages of balanced, binaural hearing. Although single-sided deafness, which is a complete loss of audibility in one ear, has gained increased interest in the published research, there is a gap in the literature concerning hearing aid outcomes for individuals with residual, or otherwise “aidable,” hearing in the affected ear. Purpose: To assess hearing aid outcomes for a group of individuals with USNHL with residual, aidable function. Research Design: A quasi-experimental study of hearing aid outcomes with paired comparisons made between unaided and aided test conditions. Study Sample: A convenience sample of twenty-two individuals with USNHL, with sufficient residual hearing in the affected ear as to receive audibility from use of a hearing aid, were recruited into the study from September 2011 to August 2012. Intervention: Each participant was fit with a digital behind-the-ear hearing aid coupled to a custom ear mold. Data Collection and Analysis: Assessments were performed at baseline (unaided) and after a three-month field trial (aided) with primary outcomes involving objective measures in sound field yielding signal-to-noise ratio loss (SNR Loss) via the Quick Speech-in-Noise Test and word recognition scores (WRS) via the Northwestern University Auditory Test, No. 6. Outcomes also involved the administration of two well-established subjective benefit questionnaires: The Abbreviated Profile of Hearing Aid Benefit (APHAB) and the 49-item Speech, Spatial, and Qualities of Hearing Scale (SSQ49). Results: As a group, participants showed significantly improved median SNR Loss thresholds when aided in a test condition that included spatial separation of speech and noise, with speech stimuli directed toward the worse ear and noise stimuli directed toward the better ear (diff. = −4.5; p < 0.001). Hearing aid use had a small, though statistically significant, negative impact on median SNR Loss thresholds, when speech and noise stimuli originated from the same 0° azimuth (diff. = 1.0; p = 0.018). This was also evidenced by the median WRS in sound field (diff. = −6.0; p = 0.006), which was lowered from 98% in the unaided state to 92% in the aided state. Results from the SSQ49 showed statistically significant improvement on all subsection means when participants were aided (p < 0.05), whereas results from the APHAB were generally found to be unremarkable between unaided and aided conditions as benefit was essentially equal to the 50th percentile of the normative data. At the close of the study, it was observed that only slightly more than half of all participants chose to continue use of a hearing aid after their participation. Conclusions: We observed that hearing aid use by individuals with USNHL can improve the SNR Loss associated with the interference of background noise, especially in situations when there is spatial separation of the stimuli and speech is directed toward the affected ear. In addition, hearing aid use by these individuals can provide subjective benefit, as evidenced by the APHAB and SSQ49 subjective benefit questionnaires.


2021 ◽  
Vol 20 (5) ◽  
pp. 63-67
Author(s):  
S. V. Surma ◽  
◽  
D. S. Klyachko ◽  
B. F. Shchegolev ◽  
E. A. Ogorodnikova ◽  
...  

The article shows that one of the alternative methods of treating moderate to severe sensorineural hearing loss can be the use of an external weak magnetic field. The proposed method is based on the coincidence of the effects caused by the exposure of an external electromagnetic field of certain parameters on the auditory nerve, and natural acoustic exposure. The similarity of reaction allows using of external magnetic fields as an artificial stimulator of the auditory system’s neural part. Induction of applied magnetic fields does not exceed 300 µT, which means that under the current legislation such fields are classified as posing no health hazard. This method was tested at Saint Petersburg Research Institute of Ear, Throat, Nose, and Speech based on relevant Ethics Committee approval and complied with informed consent standards of volunteers. 15 patients aged 18 to 45 with III and IV levels of sensorineural deafness without concomitant pathologies were tested. Threshold pure-tone audiometry was performed on each patient at 500, 1000, 2000, 3000, and 4000 Hz before and after the procedure. The results of the experiments showed that electromagnetic stimulation of auditory neurons allows increasing hearing sensitivity. The proposed procedure may not yield a tangible result in patients with auditory deprivation. Patients with hearing aids showed the most significant results. At the same time, the measurements have shown that the sound thresholds among them became 10 dB lower on the average. The non-invasiveness of the exposure provided additional comfort for the patient.


2021 ◽  
Vol 20 (5) ◽  
pp. 8-12
Author(s):  
T. Yu. Vladimirova ◽  
◽  
A. B. Martynova ◽  

The significance of asymmetric sensorineural hearing loss (ASNHL) is due to a special approach to diagnosis, followed by the process of hearing aids and auditory rehabilitation. Currently, there is no standard audiometric criterion for determining the forms of asymmetry, which significantly affects the assessment of the prevalence of ASNHL. The study aimed to assess the prevalence and classification of ASNHL forms in the older age group using two methods of calculation: 1) the difference in the average hearing threshold at speech frequencies (in the range of 0,5–4 kHz) ≥15 dB was detected in 14,14% of cases; 2) the different degree of hearing loss, according to the International classification, in the right and left ear was 35,98%. In most cases, asymmetry was manifested by bilateral sensorineural hearing loss of varying severity, prevailing in the group of long-livers – 82,6%. Given the potentially high prevalence of asymmetry depending on the audiological criterion, the results of the work are a reason for further research in the development of a unified method for verifying a clinically significant form of ASNHL.


1979 ◽  
Vol 82 (12) ◽  
pp. 1480-1485
Author(s):  
MICHI YAGI ◽  
YOSHIAKI HIRASUGI ◽  
YUKO HORIBE ◽  
SACHIKO IBATA ◽  
TOMOHIRO YASUNO

2005 ◽  
Vol 125 (7) ◽  
pp. 693-696 ◽  
Author(s):  
Maurizio Barbara ◽  
Giorgio Bandiera ◽  
Bruno Serra ◽  
Vania Marrone ◽  
Silvia Tarentini ◽  
...  

1994 ◽  
Vol 3 (2) ◽  
pp. 71-77 ◽  
Author(s):  
James J. Dempsey ◽  
Mark Ross

A large number of personal amplifiers have recently become available commercially. These devices have not been classified as hearing aids by the FDA and are therefore not subject to the FDA rules and regulations governing the sales of hearing aid devices. In this investigation, several of these personal amplifiers were evaluated to determine potential benefits and problems for each device. The devices were evaluated electroacoustically and, also, subjectively by a group of adults with sensorineural hearing loss. The results of the electroacoustic evaluation revealed very sharply peaked frequency responses. The subjective evaluations revealed tremendous variability, with some preferences for power and low-frequency amplification. Clinical implications of these results and suggestions for further research are provided.


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