Application of Active Middle Ear Implants in Patients With Severe Mixed Hearing Loss

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.

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Subjective Outcomes With Bone Conduction and Middle Ear Implants for Patients Wth Conductive or Mixed Hearing Loss

Value in Health ◽

10.1016/j.jval.2015.09.714 ◽

2015 ◽

Vol 18 (7) ◽

pp. A364

Author(s):

M Kosaner Kliess ◽

R Zoehrer ◽

B Schlick ◽

M Mariacher ◽

M Urban

Keyword(s):

Hearing Loss ◽

Middle Ear ◽

Bone Conduction ◽

Mixed Hearing Loss ◽

Middle Ear Implants ◽

Subjective Outcomes

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

The Journal of Laryngology & Otology ◽

10.1017/s0022215116000748 ◽

2016 ◽

Vol 130 (4) ◽

pp. 340-343 ◽

Cited By ~ 14

Author(s):

V A Savaş ◽

B Gündüz ◽

R Karamert ◽

R Cevizci ◽

M Düzlü ◽

...

Keyword(s):

Hearing Loss ◽

Middle Ear ◽

Hearing Aids ◽

Bone Conduction ◽

Patient Acceptance ◽

Life Questionnaire ◽

Active Middle Ear Implant ◽

Mixed Hearing Loss ◽

Glasgow Benefit Inventory ◽

Middle Ear Implants

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.

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Benefits of active middle ear implants in mixed hearing loss: Stapes versus round window

The Laryngoscope ◽

10.1002/lary.26244 ◽

2016 ◽

Vol 127 (6) ◽

pp. 1435-1441 ◽

Cited By ~ 9

Author(s):

Jeon Mi Lee ◽

Jinsei Jung ◽

In Seok Moon ◽

Sung Huhn Kim ◽

Jae Young Choi

Keyword(s):

Hearing Loss ◽

Middle Ear ◽

Round Window ◽

Mixed Hearing Loss ◽

Middle Ear Implants

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Middle ear implants: functional gain in mixed hearing loss

Brazilian Journal of Otorhinolaryngology ◽

10.1590/s1808-86942012000100017 ◽

2012 ◽

Vol 78 (1) ◽

pp. 109-112 ◽

Cited By ~ 4

Author(s):

Mario Emilio Zernotti ◽

Maria Fernanda Di Gregorio ◽

Andrea C. Bravo Sarasty

Keyword(s):

Hearing Loss ◽

Middle Ear ◽

Mixed Hearing Loss ◽

Middle Ear Implants ◽

Functional Gain

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Design Study of a Round Window Piezoelectric Transducer for Active Middle Ear Implants

Sensors ◽

10.3390/s21030946 ◽

2021 ◽

Vol 21 (3) ◽

pp. 946

Author(s):

Dong Ho Shin

Keyword(s):

Hearing Loss ◽

Sensorineural Hearing Loss ◽

Middle Ear ◽

Piezoelectric Transducer ◽

Round Window ◽

Piezoelectric Element ◽

Sensorineural Hearing ◽

Flat Band ◽

Middle Ear Implants ◽

Output Characteristics

This report describes the design of a new piezoelectric transducer for round window (RW)-driven middle ear implants. The transducer consists of a piezoelectric element, gold-coated copper bellows, silicone elastomer (polydimethylsiloxane, PDMS), metal cylinder (tungsten), and titanium housing. The piezoelectric element is fixed to the titanium housing and mechanical resonance is generated by the interaction of the bellows, PDMS, and tungsten cylinder. The dimensions of PDMS and the tungsten cylinder with output characteristics suitable for compensation of sensorineural hearing loss were derived by mechanical vibrational analysis (equivalent mechanical model and finite element analysis (FEA)). Based on the results of FEA, the RW piezoelectric transducer was implemented, and bench tests were performed under no-load conditions to confirm the output characteristics. The transducer generates an average displacement of 219.6 nm in the flat band (0.1–1 kHz); the resonance frequency is 2.3 kHz. To evaluate the output characteristics, the response was compared to that of an earlier transducer. When driven by the same voltage (6 Vp), the flat band displacement averaged 30 nm larger than that of the other transducer, and no anti-resonance was noted. Therefore, we expect that the new transducer can serve as an output device for hearing aids, and that it will improve speech recognition and treat high-frequency sensorineural hearing loss more effectively.

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Hearing Aid Treatment for Patients with Mixed Hearing Loss. Part II: Speech Recognition in Comparison to Direct Acoustic Cochlear Stimulation

Audiology and Neurotology ◽

10.1159/000504285 ◽

2020 ◽

Vol 25 (3) ◽

pp. 133-142

Author(s):

Nina Wardenga ◽

Ad F.M. Snik ◽

Eugen Kludt ◽

Bernd Waldmann ◽

Thomas Lenarz ◽

...

Keyword(s):

Hearing Loss ◽

Speech Recognition ◽

Middle Ear ◽

Hearing Aids ◽

Dynamic Range ◽

Hearing Aid ◽

Middle Ear Surgery ◽

Promising Alternative ◽

Mixed Hearing Loss ◽

Technical Specifications

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.

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The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits

Journal of Clinical Medicine ◽

10.3390/jcm10245916 ◽

2021 ◽

Vol 10 (24) ◽

pp. 5916

Author(s):

Katarzyna B. Cywka ◽

Henryk Skarżyński ◽

Bartłomiej Król ◽

Piotr H. Skarżyński

Keyword(s):

Hearing Loss ◽

Word Recognition ◽

Middle Ear ◽

Bone Conduction ◽

Free Field ◽

Subjective Assessment ◽

Congenital Defects ◽

Mixed Hearing Loss ◽

Speech Reception ◽

Bone Conduction Implant

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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