Ossiculoplasty: study of hearing results in 50 patients

Chavan, Reshma P.; Ingole, Shivraj M.; Birajdar, Santosh N.

doi:10.18203/issn.2454-5929.ijohns20170427

Cited by 5 publications

(13 citation statements)

References 8 publications

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“…With only six reports of displaced prosthesis over the 10-year period of study, compared to published rates of prosthesis displacement or extrusion of 0.8% to 19% (12–19), the present data likely represent gross underreporting. The volume of ossicular prosthesis use and associated complication rates previously reported by many single institution studies further emphasizes this point (8–10,12,19). For example, House and Teufert in 2001 reported a 4% extrusion rate in their study of 1,210 patients who underwent ossicular chain reconstruction with an ossicular prosthesis at a single tertiary healthcare facility between 1990 and 1998 (19).…”

Section: Discussionmentioning

confidence: 93%

“…PORPs and TORPs have gained widespread acceptance and may produce favorable hearing outcomes in many patients, but they also have been associated with adverse events previously reported in the literature. Among these are decreased hearing or recurrent hearing loss, tinnitus, vertigo, and otalgia (8)(9)(10)(11). Prosthesis displacement and extrusion also have been identified as significant causes of ossiculoplasty failure (12,13).…”

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confidence: 99%

“…A more thorough understanding of the causal factors responsible for these adverse events may allow development of interventions aimed at decreasing their incidence, thus improving the overall safety and efficacy of these devices. While reference guides for ossicular prostheses highlight product features designed to decrease the likelihood of various complications, and device instruction manuals may provide guidance for effective use, postmarket surveillance reporting of adverse events has been restricted to various studies based out of single institutions which are often designed to evaluate the advantages of a specific type of prosthesis or modification in technique (8)(9)(10)12,13). Although complications generally have been reported to occur infrequently, published rates of prosthesis displacement or extrusion have ranged from 0.8% to 19% (12)(13)(14)(15)(16)(17)(18).…”

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confidence: 99%

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Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database

Tong

Pasick

Benito

et al. 2021

Otology &Amp; Neurotology

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Objectives: Ossicular prostheses have demonstrated utility in ossicular chain reconstruction, but their use also is associated with complications. This study aims to explore the utility of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for the systematic analysis of complications associated with ossicular prostheses. It also summarizes adverse events to patients (AEPs) and device malfunctions (DMs) reported in the MAUDE database, and attempts to examine the consequences brought about by these events and to identify likely root causes. Study Design: Retrospective analysis of the MAUDE database. Methods: The MAUDE database was queried for reports from January 2010 to May 2020. Data were extracted from reports involving the use of ossicular prostheses. Results: Seventy-three medical device reports, reports submitted to the Food and Drug Administration detailing suspected device-associated malfunctions, injuries, and deaths, involved ossicular prostheses and were included for analysis, from which 126 adverse events were extracted. Of these, 50 (39.7%) were AEPs, while 76 (60.3%) were DMs. The most common AEPs were foreign body and hearing loss, while the DMs reported most commonly were broken prosthesis and displaced prosthesis. Of the 76 DMs, 19 (25%) were attributed to mishandling by the operator, while 6 (7.9%) were due to a defective device. Broken prosthesis was the DM most commonly attributed to mishandling by the operator in 16 (32.7%) cases. Conclusion: Ossicular prostheses are used extensively for ossicular chain reconstruction, but also are associated with adverse events. The MAUDE database in its current form does not appear sufficient for the systematic review of adverse events associated with ossicular prostheses. A more standardized reporting format with clearly defined categories and inclusion of relevant variables might improve the quality of information provided by the MAUDE database.

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Section: Discussionmentioning

confidence: 93%

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confidence: 99%

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confidence: 99%

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Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database

Tong

Pasick

Benito

et al. 2021

Otology &Amp; Neurotology

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“…In 1901, the first documented attempt at repairing the ossicular chain was made by Matte, who named this procedure myringostapediopexy (20).…”

Section: History and Evolution Of Ossicular Chain Reconstructionmentioning

confidence: 99%

Materials for ossicular chain reconstruction: History and evolution (Review)

Mocanu

Dascălu

et al. 2023

Med Int

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the middle ear represents the anatomic space between the external auditory canal and the inner ear (Cochlea). It is comprised of the tympanic membrane, the ossicular chain [malleus (hammer), incus (anvil) and stapes (stirrup)] with the corresponding muscles and ligaments and the cavity of the middle ear. the main function of the middle ear is to convey vibratory energy (sound pressure) from the air to the cochlear fluids of the internal ear via the ossicular chain. tympanoplasty represents a number of procedures used to re-establish the continuity of sound transmission from the tympanic membrane to the inner ear. Ever since the beginning of otologic surgery, various materials have been tested for ossicular chain reconstruction (oCr). the present review aimed to present, in a chronological sequence, the evolution of knowledge regarding this field of medicine, and to also discuss the advantages and disadvantages of different materials and designs of ossicular prostheses. the constant search for more efficient, easily tolerated and lighter materials has improved the acoustic rehabilitation process and has markedly reduced the rate of functional failure of these small prostheses. Contents 1. Introduction 2. Data collection 3. History and evolution of ossicular chain reconstruction 4. Conclusions and future perspectives

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“…Since the first half of the 20th century, hearing protection or restoration has also become a second priority of treatment [5] . Reconstruction of the ossicular chain can be performed using autologous cartilage, bone, or synthetic materials such as vinylacryl, polyethylene, gold, plastipore, hydroxyapatite, bioglass and titanium [6] .…”

Section: Introductionmentioning

confidence: 99%