Comparison of Carina active middle-ear implant with conventional hearing aids for mixed hearing loss

2016 ◽  
Vol 130 (4) ◽  
pp. 340-343 ◽  
Author(s):  
V A Savaş ◽  
B Gündüz ◽  
R Karamert ◽  
R Cevizci ◽  
M Düzlü ◽  
...  

AbstractObjective:To compare the auditory outcomes of Carina middle-ear implants with those of conventional hearing aids in patients with moderate-to-severe mixed hearing loss.Methods:The study comprised nine patients (six males, three females) who underwent middle-ear implantation with Carina fully implantable active middle-ear implants to treat bilateral moderate-to-severe mixed hearing loss. The patients initially used conventional hearing aids and subsequently received the Carina implants. The hearing thresholds with implants and hearing aids were compared.Results:There were no significant differences between: the pre-operative and post-operative air and bone conduction thresholds (p> 0.05), the thresholds with hearing aids and Carina implants (p> 0.05), or the pre-operative (mean, 72.8 ± 19 per cent) and post-operative (mean, 69.9 ± 24 per cent) speech discrimination scores (p> 0.05). One of the patients suffered total sensorineural hearing loss three months following implantation despite an initial 38 dB functional gain. All except one patient showed clinical improvements after implantation according to quality of life questionnaire (Glasgow Benefit Inventory) scores.Conclusion:Acceptance of Carina implants is better than with conventional hearing aids in patients with mixed hearing loss, although both yield similar hearing amplification. Cosmetic reasons appear to be critical for patient acceptance.

2020 ◽  
Vol 25 (3) ◽  
pp. 125-132
Author(s):  
Nina Wardenga ◽  
Victoria Diedrich ◽  
Bernd Waldmann ◽  
Thomas Lenarz ◽  
Hannes Maier

Objective: The purpose of the present study was to determine the fraction of patients with mixed hearing loss who can or cannot expect benefit from power hearing aids (HAs) after stapes surgery. Design: The audiological outcome of 374 stapes surgeries was used to calculate the patients’ individual postoperative requirements in terms of gain and output of HAs. These requirements were compared to the available gain and output provided by state-of-the-art power HAs at 0.5, 1.0, 2.0, and 4.0 kHz. According to these comparisons, ears were divided into three groups. For G0, required gain and output lay within the corresponding technical limits of the HAs at all frequencies. In G1, one or both requirements could not be fulfilled at 1 frequency. G2 combined all ears where the requirements lay beyond the HA’s technical limitations at 2 or more frequencies. Results: Stapes surgery resulted in an improvement of air-bone gap (ABG) in 84.5% of the cases by 15.7 dB on average. Based on pure-tone average (0.5, 1.0, 2.0, 4.0 kHz), 40.6% of all cases showed an ABG ≤10 dB. 44.9% of all cases did no longer need a HA after stapes surgery. A power HA would fulfill both audiological criteria at all 4 frequencies in 81.6% of cases that needed a HA postoperatively. However, 18.4% would not be sufficiently treatable at 1 or more frequencies (15.0% in G1, 3.4% in G2). Conclusions: The present study identified a subset of patients with mixed hearing loss after stapes surgery that cannot be treated sufficiently with available power HAs. As the residual ABG is an important reason for this lack of treatment success, the advancement of alternative hearing devices that circumvent the middle ear, such as powerful active middle ear implants, is indicated.


2015 ◽  
Vol 18 (7) ◽  
pp. A364
Author(s):  
M Kosaner Kliess ◽  
R Zoehrer ◽  
B Schlick ◽  
M Mariacher ◽  
M Urban

2013 ◽  
Vol 127 (S2) ◽  
pp. S8-S16 ◽  
Author(s):  
C L Butler ◽  
P Thavaneswaran ◽  
I H Lee

AbstractIntroduction:This systematic review aims to advise on the effectiveness of the active middle-ear implant in patients with sensorineural hearing loss, compared with external hearing aids.Methods:A systematic search of several electronic databases, including PubMed and Embase, was used to identify relevant studies for inclusion.Results:Fourteen comparative studies were included. Nine studies reported on the primary outcome of functional gain: one found that the middle-ear implant was significantly better than external hearing aids (p < 0.001), while another found that external hearing aids were generally significantly better than middle-ear implants (p < 0.05). Six of the seven remaining studies found that middle-ear implants were better than external hearing aids, although generally no clinically significant difference (i.e. ≥10 dB) was seen.Conclusion:Generally, the active middle-ear implant appears to be as effective as the external hearing aid in improving hearing outcomes in patients with sensorineural hearing loss.


2018 ◽  
Vol 23 (6) ◽  
pp. 316-325 ◽  
Author(s):  
Thomas Zahnert ◽  
Robert Mlynski ◽  
Hubert Löwenheim ◽  
Dirk Beutner ◽  
Rudolf Hagen ◽  
...  

Objective: To evaluate the long-term safety and performance of four different vibroplasty couplers (round window, oval window, CliP and Bell coupler) in combination with an active middle ear implant. Methods: This was a multicentre, prospective, long-term study including 5 German hospitals. Thirty adult subjects suffering from conductive or mixed hearing loss were initially enrolled for the study, 24 of these were included in the final analysis with up to 36 months of postsurgical follow-up data. Bone conduction and air conduction were measured pre- and postoperatively to evalu ate safety. Postoperative aided sound field thresholds and Freiburger monosyllable word recognition scores were compared to unaided pre-implantation results to confirm performance. Additional speech tests compared postoperative unaided with aided results. To determine patient satisfaction, an established quality-of-life questionnaire developed for conventional hearing aid usage was administered to all subjects. Results: Mean postoperative bone conduction thresholds remained stable throughout the whole study period. Mean functional gain for all couplers investigated was 38.5 ± 11.4 dB HL (12 months) and 38.8 ± 12.5 dB HL (36 months). Mean word recognition scores at 65 dB SPL increased from 2.9% in the unaided by 64.2% to 67.1% in the aided situation. The mean postoperative speech reception in quiet (or 50% understanding of words in sentences) shows a speech intelligibility improvement at 36 months of 17.8 ± 12.4 dB SPL over the unaided condition. The signal-to-noise ratio (SNR) improved by 5.9 ± 7.2 dB SNR over the unaided condition. High subjective device satisfaction was reflected by the International Inventory for Hearing Aids scored very positively. Conclusion: A significant improvement was seen with all couplers, and audiological performance did not significantly differ between 12 and 36 months after surgery.


2021 ◽  
Vol 11 (4) ◽  
pp. 508-523
Author(s):  
Kimio Shiraishi

Sound localization in daily life is one of the important functions of binaural hearing. Bilateral bone conduction devices (BCDs), middle ear implants, and cartilage conduction hearing aids have been often applied for patients with conductive hearing loss (CHL) or mixed hearing loss, for example, resulting from bilateral microtia and aural atresia. In this review, factors affecting the accuracy of sound localization with bilateral BCDs, middle ear implants, and cartilage conduction hearing aids were classified into four categories: (1) types of device, (2) experimental conditions, (3) participants, and (4) pathways from the stimulus sound to both cochleae. Recent studies within the past 10 years on sound localization and lateralization by BCDs, middle ear implants, and cartilage conduction hearing aids were discussed. Most studies showed benefits for sound localization or lateralization with bilateral devices. However, the judgment accuracy was generally lower than that for normal hearing, and the localization errors tended to be larger than for normal hearing. Moreover, it should be noted that the degree of accuracy in sound localization by bilateral BCDs varied considerably among patients. Further research on sound localization is necessary to analyze the complicated mechanism of bone conduction, including suprathreshold air conduction with bilateral devices.


2021 ◽  
Vol 75 (4) ◽  
pp. 1-5
Author(s):  
Joanna Marszał ◽  
Renata Gibasiewicz ◽  
Magdalena Błaszczyk ◽  
Maria Gawlowska ◽  
Wojciech Gawęcki

Introduction: Nowadays, there are many options to treat hearing-impaired patients: tympanoplastic surgery, hearing aids and a wide range of implantable devices. Objective: The aim of this study is to present the mid-term audiological and quality of life benefits after the implantation of the Osia®, a new active piezoelectric bone conduction hearing implant. Material and methods: The state of the tissues in implanted area, as well as audiological and quality of life results were analyzed six, nine and twelve months after implantation in a group of four adult patients with bilateral mixed hearing loss. Results: In all the cases, no postoperative complications were found. One year after surgery the mean audiological gain in FF PTA4 (pure tone average for 0.5, 1, 2, and 4 kHz) was 52.2±3.5 dB in comparison to the unaided situation, the mean speech understanding with Osia® in quiet was 90±8.2% for 50dB SPL, 98.8±2.5% for 65dB SPL and 100±0% for 80dB SPL, and mean speech understanding with Osia® in noise was 37.5%±23.6 for 50dB SPL, 93.8±4.8% for 65dB SPL and 98.8±2.5% for 80dB SPL. There was also an evident improvement in the quality of hearing as well as in the quality of life, measured by the APHAB (Abbreviated Profile of Hearing Aid Benefit) and the SSQ (Speech, Spatial and Qualities of Hearing Scale). Conclusions: The Osia® is an effective treatment option for patients with bilateral mixed hearing loss. The mid-term audiological and quality of life results are excellent, but further observations including bigger groups of patients and a longer follow-up are required.


2020 ◽  
Vol 25 (3) ◽  
pp. 133-142
Author(s):  
Nina Wardenga ◽  
Ad F.M. Snik ◽  
Eugen Kludt ◽  
Bernd Waldmann ◽  
Thomas Lenarz ◽  
...  

Background: The conventional therapy for severe mixed hearing loss is middle ear surgery combined with a power hearing aid. However, a substantial group of patients with severe mixed hearing loss cannot be treated adequately with today’s state-of-the-art (SOTA) power hearing aids, as predicted by the accompanying part I of this publication, where we compared the available maximum power output (MPO) and gain from technical specifications to requirements for optimum benefit using a common fitting rule. Here, we intended to validate the theoretical assumptions from part I experimentally in a mixed hearing loss cohort fitted with SOTA power hearing aids. Additionally, we compared the results with an implantable hearing device that circumvents the impaired middle ear, directly stimulating the cochlea, as this might be a better option. Objectives: Speech recognition outcomes obtained from patients with severe mixed hearing loss supplied acutely with a SOTA hearing aid were studied to validate the outcome predictions as described in part I. Further, the results obtained with hearing aids were compared to those in direct acoustic cochlear implant (DACI) users. Materials and Methods: Twenty patients (37 ears with mixed hearing loss) were provided and fitted with a SOTA power hearing aid. Before and after an acclimatization period of at least 4 weeks, word recognition scores (WRS) in quiet and in noise were studied, as well as the speech reception threshold in noise (SRT). The outcomes were compared retrospectively to a second group of 45 patients (47 ears) using the DACI device. Based on the severity of the mixed hearing loss and the available gain and MPO of the SOTA hearing aid, the hearing aid and DACI users were subdivided into groups with prediction of sufficient, partially insufficient, or very insufficient hearing aid performance. Results: The patients with predicted adequate SOTA hearing aid performance indeed showed the best WRS in quiet and in noise when compared to patients with predicted inferior outcomes. Insufficient hearing aid performance at one or more frequencies led to a gradual decrease in hearing aid benefit, validating the criteria used here and in the accompanying paper. All DACI patients showed outcomes at the same level as the adequate hearing aid performance group, being significantly better than those of the groups with inadequate hearing aid performance. Whereas WRS in quiet and noise were sensitive to insufficient gain or output, showing significant differences between the SOTA hearing aid and DACI groups, the SRT in noise was less sensitive. Conclusions: Limitations of outcomes in mixed hearing loss individuals due to insufficient hearing aid performance can be accurately predicted by applying a commonly used fitting rule and the 35-dB dynamic range rule on the hearing aid specifications. Evidently, when outcomes in patients with mixed hearing loss using the most powerful hearing aids are insufficient, bypassing the middle ear with a powerful active middle ear implant or direct acoustic implant can be a promising alternative treatment.


2007 ◽  
Vol 117 (3) ◽  
pp. 552-555 ◽  
Author(s):  
Frederic Venail ◽  
Jean Pierre Lavieille ◽  
Renaud Meller ◽  
Arnaud Deveze ◽  
Laurent Tardivet ◽  
...  

2021 ◽  
Vol 10 (24) ◽  
pp. 5916
Author(s):  
Katarzyna B. Cywka ◽  
Henryk Skarżyński ◽  
Bartłomiej Król ◽  
Piotr H. Skarżyński

Background: the Bonebridge hearing implant is an active transcutaneous bone conduction implant suitable for various types of hearing loss. It was first launched in 2012 as the BCI 601, with a newer internal part (BCI 602) released in 2019. With the new size and shape, the BCI 602 can be used in patients previously excluded due to insufficient anatomical conditions, especially in patients with congenital defects of the outer and middle ear. Objectives: the purpose of this study is to evaluate the objective and subjective benefits of the new Bonebridge BCI 602 in children who have hearing impairment due to conductive or mixed hearing loss. Safety and effectiveness of the device was assessed. Methods: the study group included 22 children aged 8–18 years (mean age 14.7 years) who had either conductive or mixed hearing loss. All patients were implanted unilaterally with the new Bonebridge BCI 602 implant. Pure tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed before and after implantation. Word recognition scores were evaluated using the Demenko and Pruszewicz Polish Monosyllabic Word Test, and speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. The subjective assessment of benefits was carried outusing the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. Results: after implantation of the Bonebridge BCI 602 all patients showed a statistically significant improvement in hearing and speech understanding. The mean word recognition score (WRS) changed from 12.1% before implantation to 87.3% after 6 months. Mean speech reception threshold (SRT) before implantation was +4.79 dB SNR and improved to −1.29 dB SNR after 6 months. All patients showed stable postoperative results. The APHAB questionnaire showed that difficulties in hearing decreased after implantation, with a statistically significant improvement in global score. Pre-operative scores (M = 35.7) were significantly worse than post-operative scores at 6 months (M = 25.7). Conclusions: the present study confirms that the Bonebridge BCI 602 is an innovative and effective solution, especially for patients with conductive and mixed hearing loss due to anatomical ear defects. The Bonebridge BCI 602 system provides valuable and stable audiological and surgical benefits. Subjective assessment also confirms the effectiveness of the BCI 602. The BCI 602 offers the same amplification as the BCI601, but with a smaller size. The smaller dimensions make it an effective treatment option for a wider group of patients, especially children with congenital defects of the outer and middle ear.


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