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A post-marketing, single-center, single-group clinical study designed to evaluate the effectiveness and safety of Pinyin® tooth bone conduction hearing system for improving the hearing ability reconstruction of patients with single-sided deafness (SSD) after acoustic neuroma surgery

A post-marketing, single-center, single-group clinical study designed to evaluate the effectiveness and safety of Pinyin® tooth bone conduction hearing system for improving the hearing ability reconstruction of patients with single-sided deafness (SSD) after acoustic neuroma surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071536
Enrollment
Unknown
Registered
2023-05-17
Start date
2023-05-22
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acoustic neuroma

Interventions

all group:wearing Bone Conduction Hearing System

Sponsors

SunYat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Chinese population over 18 years old and under 80 years old (including 18 and 80 years old) 2) Can understand and repeat Mandarin Chinese as judged by the principal investigator 3) The subjects signed the informed consent form with good compliance 4) Patients with postoperative acoustic neuroma, AAO-HNS hearing assessment grade C or D 5) Two consecutive teeth on at least one side of the maxillary posterior alveolar (implants are acceptable, but dentures are not acceptable)

Exclusion criteria

Exclusion criteria: 1) Currently using other bone conduction hearing aids, such as Baha Attract, Bone bridge, etc. 2) Those who are allergic to epoxy resin polymers 3) Known to have a life-threatening disease, or have a contraindication to the chosen dental or medical procedure 4) Known medical conditions that may interfere with the efficacy of the medical treatment, such as inability to breathe through the nasal passages (severe perennial allergic rhinitis, chronic sinusitis with nasal polyps) 5) The teeth are known to have the following abnormalities: a. Wearing a temporary crown or undergoing dental treatment; b. No continuously available molars; c. Currently undergoing orthodontic treatment; d. There are one or more caries that have not been treated in the range of the target teeth where the device is worn; e. Suffering from moderate to severe periodontitis around the target tooth where the device is worn; f. Suspected oral or facial injury or swelling of any type; g. Severe pain to palpation in any area of the mouth, face or neck; h. Moderate to severe heat sensitivity of the teeth on the upper side of the mouth; i. The subject is currently undergoing temporomandibular joint treatment, pain, full mouth reconstruction or posterior dental implants 6) Known psychological or psychiatric problems that may interfere with compliance, understanding, knowledge, and ability to cooperate 7) Those who have received less than 6 years of education and have speech comprehension impairments 8) The investigator believes that it may hinder the evaluation of the results or pose a health risk to the subjects

Design outcomes

Primary

MeasureTime frame
The overall effectiveness of the subjects wearing the test device;

Secondary

MeasureTime frame
Pure tone air conduction hearing threshold change value;sound source localization ability;percentage of subjects with significantly improved hearing aid effect;device performance of the test device;

Countries

China

Contacts

Public ContactSuijun Chen

SunYat-Sen Memorial Hospital of Sun Yat-Sen University

chensuijun1974@163.com+86 136 0975 7219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026