Brazilian Society of Otology task force - Otosclerosis: evaluation and treatment.

OBJECTIVES: To review and provide evidence-based recommendations for the diagnosis and treatment of otosclerosis. METHODS: Task force members were educated on knowledge synthesis methods, including electronic database search, review and selection of relevant citations, and critical appraisal of selected studies. Articles written in English or Portuguese on otosclerosis were eligible for inclusion. The American College of Physicians' guideline grading system and the American Thyroid Association's guideline criteria were used for critical appraisal of evidence and recommendations for therapeutic interventions. RESULTS: The topics were divided into 2 parts: 1) Diagnosis - audiologic and radiologic; 2) Treatment - hearing AIDS, pharmacological therapy, stapes surgery, and implantable devices - bone-anchored devices, active middle ear implants, and Cochlear Implants (CI). CONCLUSIONS: The pathophysiology of otosclerosis has not yet been fully elucidated, but environmental factors and unidentified genes are likely to play a significant role in it. Women with otosclerosis are not at increased risk of worsening clinical condition due to the use of contraceptives or during pregnancy. Drug treatment has shown little benefit. If the patient does not want to undergo stapedotomy, the use of hearing aids is well indicated. Implantable systems should be indicated only in rare cases, and the CI should be indicated in cases of profound deafness.

[Coupling of active middle ear implants-biomechanical aspects]. / Ankopplung aktiver Mittelohrimplantate ­ biomechanische Aspekte.

Active middle ear implants or implantable hearing aids are used to treat sensorineural or combined hearing loss. Their coupling to the middle ear structures has a large impact on the success of rehabilitation. Practical issues such as the coupling site, influence of middle ear status, and forward and backward excitation of the inner ear are discussed in the context of biomechanics. For this purpose, experimental studies, model simulations, and current literature data are evaluated. The explanations are intended to contribute to a better understanding of certain procedures in hearing rehabilitation with active implants.

Implantation of a new active bone conduction hearing device with optimized geometry.

Here, we describe the surgical technique for implanting a new, active, transcutaneous bone conduction hearing aid. The implant technology is based on a system that has been in use reliably since 2012. The geometry of the new implant has been adapted based on experience with previously introduced implants. The surgery was feasible, standardized, and safe. Due to the optimized geometric design that improved the bone fit, it is not necessary to use specialized, detailed preoperative planning, except in challenging anatomical conditions; e.g., in young children, malformations, poor pneumatization, or after a canal wall down mastoidectomy.

[Implantation of a new active bone conduction hearing device with optimized geometry. German version]. / Implantation eines neuen, aktiven, knochenverankerten elektronischen Hörimplantats mit verkleinerter Geometrie.

Here, we describe the surgical technique for implanting a new, active, transcutaneous bone conduction hearing aid. The implant technology is based on a system that has been in use reliably since 2012. The geometry of the new implant has been adapted based on experience with previously introduced implants. The surgery was feasible, standardized, and safe. Due to the optimized geometric design that improved the bone fit, it is not necessary to use specialized, detailed preoperative planning, except in challenging anatomical conditions; e.g., in young children, malformations, poor pneumatization, or after a canal wall down mastoidectomy.

Ten years of experience with the Ponto bone-anchored hearing system-A systematic literature review.

BACKGROUND: Bone-anchored hearing systems (BAHSs) are widely used for hearing rehabilitation and are indicated in cases of conductive and mixed hearing loss and in single-sided deafness. The Ponto system, that is one available option, has been on the market since 2009. OBJECTIVE OF REVIEW: The aim of this study is to systematically review the literature reporting on the Ponto system, with regard to audiological and surgical outcomes and patient's quality-of-life scores. TYPE OF REVIEW: A systematic literature search was performed in the PubMed database 2009-July 2019. SEARCH STRATEGY: Search term: ((osseointegrated hearing aid) OR (bone conduction implant) OR (bone anchored hearing) OR BAHA OR BAHS OR BAHI). Pre-defined inclusion and exclusion criteria were applied. EVALUATION METHOD: English-language articles reporting original clinical data (audiological, surgical or quality-of-life outcomes) on the Ponto system were included. Articles reporting on Ponto and another BAHS system where the results on Ponto constituted less than 50% of the patient population or including only results on testband or softband devices were excluded. RESULTS: Audiological outcomes were discussed in 20 publications. Improvement against the unaided thresholds was demonstrated. The functional improvement was on average 33.9 dB. The effective gain or remaining air-bone gap was on average 6.7 dB. All evaluated data showed aided speech reception thresholds significantly below normal speech level. Twenty-seven publications reported surgical and follow-up data for the Ponto system. Implant survival was 97.7%, adverse skin reactions (Holgers ≥ 2) were 5% across visits and 15% across patients. No complications were life-threatening, causing permanent disability/damage or requiring a hospitalisation. Five studies reported quality of life using the Glasgow benefit inventory, 98% reported an improvement when analysing the score on an individual level. CONCLUSIONS: The outcomes of this systematic review confirm that percutaneous systems provide consistent audiological benefits and improved quality of life for patients. Further, the review demonstrates that the percutaneous systems are safe, with relatively low complication rates. Skin-related complications are the most common complication type and are experienced by approximately one patient out of seven, or in less than one of 20 follow-up visits.

Resultados audiológicos y de calidad de vida en pacientes con transición del sistema BAHA Connect® a BAHA Attract® / Audiological and quality of life outcomes in patients with transition from BAHA Connect® to BAHA Attract®

Introducción: los implantes auditivos de conducción ósea percutáneos han sido usados de forma exitosa; sin embargo, un número importante de pacientes reportan reacciones repetitivas en la piel. En esta medida, los implantes auditivos transcutáneos son una alternativa que puede solventar estas complicaciones. Con este estudio queremos describir los resultados audiológicos y de calidad de vida en los pacientes que requirieron una transición del sistema percutáneo al transcutáneo. Metodología: estudio observacional descriptivo de corte transversal, en el que se incluyeron pacientes con un implante auditivo percutáneo, quienes requirieron una transición al sistema transcutáneo. El desempeño auditivo se evaluó utilizando una prueba con fondo ruidoso, y se aplicó la escala de calidad de vida Glasgow Benefit Inventory (GBI). Resultados: se incluyeron 8 pacientes, 3 de ellos con cirugía bilateral, para 11 oídos. El implante percutáneo fue usado en promedio = 9,5 ± 5,0 años, y la razón de la transición fueron reacciones reiterativas en la piel. Los resultados auditivos muestran un buen desempeño, tanto en los umbrales en silencio = 37,1 ± 6,1 dB, como en el reconocimiento del habla en ambientes ruidosos = 71,2 % ± 19,8, medidas significativamente mejores que los resultados sin implante (p <0,05). La relación señal/ruido fue = -2,6 ± 2,7 dB. Los resultados de la escala GBI mostraron un cambio positivo tanto en el resultado global (mediana = +34,75) como en las tres subescalas (mediana; estado general = +35,4, relaciones sociales = +41,65, salud física = +33,3). Conclusión: la transición de un dispositivo de conducción ósea percutáneo a uno transcutáneo puede realizarse de forma segura y efectiva. Se encontró un desempeño auditivo satisfactorio con el uso del implante transcutáneo, así como un cambio positivo en la percepción de la calidad de vida.

Introduction: the percutaneous bone-anchored hearing aid, has been successfully used. However, a significant number of patients report repetitive skin reactions. The transcutaneous bone-anchored hearing aid is an alternative that can solve these complications. With this study we aim to describe the audiological results and changes in the quality of life in patients who required transition from the percutaneous to the transcutaneous system. Methods: cross-sectional, descriptive observational study, patients with percutaneous hearing implants who required transition to the transcutaneous system were included. Hearing performance was assessed using a noisy background test and the quality of life scale Glasgow Benefit Inventory (GBI) was applied. Results: 8 patients were included, 3 of them with bilateral surgery, for 11 ears. The percutaneous implant was used on average = 9.5 ± 5.0 years, the reason for the transition was repetitive skin reactions. The auditory results show good performance, both in thresholds in silence = 37.1 ± 6.1 dB, and in speech recognition in noisy environment = 71.2% ± 19.8. These measures are significantly better than the results without implant, p <0.05. The signal/noise ratio was = -2.6 ± 2.7 dB. The results of the GBI scale showed a positive change, both in the overall result (median = +34.75), and in the three subscales (median; general state = +35.4, social relations = +41.65, physical health = +33.3). Conclusion: the transition from a percutaneous to a transcutaneous bone-anchored hearing aid can be performed safely and effectively. Satisfactory hearing performance was found with the use of the transcutaneous implant; as well as a positive change in the perception of quality of life.

ACTIVE MIDDLE EAR VIBRANT SOUNDBRIDGE SOUND IMPLANT.

The Vibrant Soundbridge represents a new approach to hearing improvement in the form of active implantable middle ear hearing device. Unlike conventional acoustic hearing aids, which increase the volume of sound that goes to the eardrum, the Vibrant Soundbridge bypasses the ear canal and eardrum by directly vibrating the small bones in the middle ear. Because of its design, no portion of the device is placed in the ear canal itself. The Vibrant Soundbridge has been approved by the FDA as a safe and effective treatment option for adults with moderate to severe sensorineural, conductive or mixed hearing losses who desire an alternative to the acoustic hearing aids, for better hearing. The paper presents a review of the active middle ear implant Vibrant Soundbridge, which has been also implanted at the Department of Otorhinolaryngology and Head and Neck Surgery, Sestre milosrdnice University Hospital Center, which is the Referral Center for Cochlear Implantation and Surgery of Hearing Impairment and Deafness of the Ministry of Health, Republic of Croatia.

Successful hearing improvement with direct acoustic stimulation in a patient with schizophrenia.

OBJECTIVE: A direct acoustic cochlear implant provides its power directly to the inner ear by vibrating the perilymph via a conventional stapes prosthesis. Our experience with a patient with severe mixed hearing loss due to otosclerosis is described.Case reportThe patient, a 47-year-old male, had a pre-operative speech recognition score of 10 per cent and had been treated for many years for schizophrenia, both of which made him a poor candidate for a direct acoustic stimulation device. Nevertheless, the surgery was performed, which preserved the pre-operative bone conduction level and significantly improved hearing. His speech recognition score rose to 100 per cent. He uses the device all day and his auditory hallucinations have subsided. Improvement of schizophrenia symptoms has enabled the patient to reduce his psychiatric medications intake. CONCLUSION: Hearing restoration was the main reason for the reduction of auditory hallucinations in our patient. Hearing loss is a potentially reversible risk factor for psychosis, but this association is often overlooked.

Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review.

BACKGROUND: The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders, there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. OBJECTIVE OF REVIEW: To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. TYPE OF REVIEW: Systematic review. SEARCH STRATEGY: Systematic review of the literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. EVALUATION METHOD: Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcome measures that had been extracted were then grouped into domains. RESULTS: The literature search resulted in the identification of 1434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised into 22 domains. CONCLUSIONS: The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcome measures are most suitable for inclusion in the core set.

[New clinical applications for laser Doppler vibrometry in otology]. / Neue klinische Anwendungen der Laser-Doppler-Vibrometrie in der Otologie.

BACKGROUND: An instrument to measure vibration in the middle ear needs to be sensitive enough to detect displacement on a nanometer scale, yet not affect the vibration itself. Numerous techniques have been described in the literature, but laser Doppler vibrometry (LDV) has nowadays become established as the standard method in hearing research. OBJECTIVE: This article aims to present possible clinical applications of an LDV system in otology. MATERIALS AND METHODS: A commercially available single-point vibrometer was used. Measurements were carried out both with the sensor head mounted on an operating microscope and as a handheld device with the sensor head manually inserted in the ear canal. For the latter, a custom-made unit containing an electrically tunable lens was attached to the sensor head. Middle ear vibrations were measured in a temporal bone model as well as in patients during and after implantation of a Vibrant Soundbridge (VSB; MED-EL Corp., Durham/NC, USA). RESULTS: Different types of middle ear pathologies can be distinguished by the frequency response of the umbo. The LDV technique can be used for intraoperative quantification of the coupling quality of the VSB's Floating Mass Transducer (FMT; MED-EL) to the ossicle chain during VSB implantation. Postoperatively, the method serves as a follow-up testing tool if a deterioration in aided hearing threshold occurs. The measurement can reveal changes in the umbo transfer function, e. g., due to middle ear scarring or dislocation of the FMT. CONCLUSION: Many clinical questions in otology can be addressed by LDV. However, due to the high acquisition costs of an LDV system, the relatively large instrumental setup, and the large inter-ear variability of middle-ear function, the technique has not (yet) become established in clinical routine.

Prótese implantável do ouvido médio: ganho funcional em perda auditiva mista / Middle ear implants: functional gain in mixed hearing loss

Atresia óssea e otite média crônica são os principais grupos de beneficiários com implantes do ouvido médio. Cirurgia de atresia é tecnicamente complexo, tem muitas complicações e resultados funcionais pobres. Os aparelhos auditivos osseointegrados são uma alternativa. Eles fornecem um ganho funcional muito bom, mas tem muitos problemas de pele e osseointegração. Na otite média crônica, ossiculoplastias resolveram parcialmente o problema de audição. Infelizmente, em alguns casos de otites média e cavidades abertas, equipamentos com aparelhos auditivos convencionais são difíceis e muitas vezes insatisfatórios. OBJETIVO: Determinar a utilidade de um implante do ouvido médio. Desenho de estudo longitudinal. MÉTODOS: Vibrant-Soundbrigde foi implantado em oito pacientes com perda auditiva mista grave. Quatro apresentavam otite média crônica e quatro apresentavam atresia unilateral. A colocação do estimulador (FMT ou Floating Mass Transducer) foi em cinco pacientes na janela redonda, dois no estribo e um na janela oval. RESULTADOS: Ganho funcional foi de 35 dB, 40 dB, 48,7 dB e 50 dB para as frequências de 500, 1000, 2000 e 4000 Hz, respectivamente. CONCLUSÃO: Vibrant-Soundbrigde é uma excelente opção no restabelecimento da audição em perda auditiva mista grave e profunda. Ele fornece um excelente ganho funcional em doenças de difícil tratamento com equipamentos convencionais.

Osseous atresia and chronic otitis media are diseases benefit with middle ear implants. Surgery for atresia is technically complicated, has significant number of complications and functional results are often poor. The osseointegrated hearing aids are an alternative. They provide a very good functional gain, but have many problems with the skin and osseointegration. In chronic otitis media, the ossiculoplasty solved partially the hearing problem. Unfortunately in some cases of otitis media and in open cavities fitted with conventional hearing aids the gain is unsatisfactory. AIM: To determine the usefulness of an active middle ear implant. MATERIAL AND METHOD: Longitudinal Study. Vibrant- Soundbrigde was implanted in eight patients with severe mixed hearing loss. Four patients had chronic otitis media and four had unilateral atresia. The placement of the stimulator (FMT or Floating Mass Transducer) was in five patients on round window, two in stapes and one in the oval window. RESULTS: Functional gain was 35 dB, 40 dB, 48.7 dB and 50 dB for the frequencies 500, 1000, 2000 and 4000 Hz, respectively. CONCLUSION: Vibrant-Soundbrigde is an excellent option in hearing recovery in severe and profound mixed hearing loss. It also provides an excellent functional gain in diseases difficult to treat with conventional hearing aids.

Perfil de usuários de AASI com fissura labiopalatina / Profile of patients with cleft palate fitted with hearing AIDS

Afissura labiopalatina, por provocar alterações nas estruturas do lábio e do palato, pode causar comprometimento auditivo, devido às otites médias recorrentes. O tratamento mais adequado é controverso, podendo ser indicado o uso de antibióticos e inserção do tubo de ventilação, ou o acompanhamento otorrinolaringológico, audiológico e reabilitação aural, com uso de aparelho de amplificação sonora individual (AASI). Objetivo: Caracterizar o perfil dos pacientes com fissura labiopalatina e deficiência auditiva, adaptados com AASI e acompanhados pelo setor de Otorrinolaringologia e Fonoaudiologia de um hospital especializado em anomalias craniofaciais e deficiência auditiva. Estudo Retrospectivo. Material e método: Análise retrospectiva de 131 prontuários de pacientes com fissura labiopalatina operada e deficiência auditiva, adaptados com AASI pelo referido centro. Resultados: O perfil geral (n=131) caracterizou-se pela predominância do gênero feminino (53 por cento), fissura transforame incisivo unilateral (27 por cento), presença de anomalias associadas (51 por cento), histórico de alterações de orelha média (56 por cento) e intervenção cirúrgica (56 por cento). Conclusão: O perfil geral dos pacientes com fissura labiopalatina e deficiência auditiva, adaptados com AASI, caracterizou-se pela predominância da fissura de lábio e palato, histórico positivo de alteração de orelha média, intervenção cirúrgica e deficiência auditiva sensorioneural bilateral.

Cleft palates cause alterations in palate and lip structures, and it may also cause hearing loss because of recurrent otitis media. The appropriate treatment is controversial. It may include the prescription of antibiotics and insertion of a ventilation tube, or even otorhinolaryngological and audiological assistance, and hearing rehabilitation, with the use of an individual sound amplifier aid (ISAA). AIM: To characterize the profile of individuals with cleft palate and hearing loss, users of ISAA are assisted by the center of otorhinolaryngology and speech therapy of a hospital specialized in craniofacial anomalies and hearing impairment. Retrospective Study. Material and methods: Retrospective analysis of 131 charts of patients with corrected cleft palate and hearing loss, fitted with ISAA by the center abovementioned. Results: The sample (n=131) was characterized by a prevalence of females (53 percent), unilateral incisive transforaminal cleft (27 percent), presence of associated anomalies (51 percent), history of alterations of the middle ear (56 percent) and surgery intervention (56 percent). Conclusion: The general profile of the individuals with cleft palate and hearing loss, fitted with ISAA, was characterized by the predominance of cleft lip and palate, positive history of middle ear alterations, surgery intervention and bilateral sensorineural hearing loss.