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Quell sound generators are designed for individuals who experience tinnitus. These devices generate a digitally controlled passive analog broad band noise from the circuit. The broad band noise is intended for use with tinnitus masking therapy. These devices are to be dispensed only by a doctor, licensed audiologist, or licensed hearing instrument specialist who are trained in the area of tinnitus treatment. BTE worn sound generators are one of several available sound stimuli means such as; computer generated audio, CD player, iPod, sound pillows, etc. Sound generators are dispensed to an adult population 18 years of age or above with specific instructions for their use.

The Quell 908TD is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. These devices are programmable and offer the ability to adjust the frequency level of the masking sound to fit the individual user's needs. The programming can be done by hearing healthcare professionals using a standard HI-PRO box and Amplisound's Hearing Studio software. The Quell device resembles a miniature behind the ear (BTE) hearing aid. This style device sits on top of and just behind the pinna of the ear and has an acoustic soundtip connected to it. The soundtip is a removable and interchangeable tubing of different lengths, left and right, which carries the sound from the ear. The soundtip connects to the device at one end and bends around the front of the pinna to the other end which is connected to a dome tip which fits inside the ear canal. Quell devices operate on a hearing aid battery and have an easily operated user volume control wheel. The wearer adjusts the sound to a desired loudness level by rolling the volume wheel with a fingertip.

Sound generators can be used for persons who suffer from tinnitus in conjunction with a sound therapy program such as Tinnitus Retraining Therapy (TRT). The sound therapy provides the tinnitus sufferer with an adjustable external sound source to mitigate the presence and annoyance of their personal internal noise.

The Quell 908TD sound generator consists of a miniature digital amplifier and speaker powered by a 1.4 volt battery packaged inside a small hearing aid shaped housing and which generates a digitally adjustable broad band white noise. White noise is defined as noise containing many frequencies at similar intensities. The bandwidth is adjustable from the broadest range of 750Hz to 8KHz, to the narrowest of 1250Hz to 3850Hz. The broad band noise is delivered through a small tubing connected to the housing which curves around the pinna and then is placed inside the ear canal. This small tubing is called a 'soundtip' which comes in left and right sides in short, medium and long lengths. There is a small plastic locking handle which helps retain the device in the ear, and a replaceable open dome tip in 6, 8, 10mm sizes to help the tip be comfortable and well seated in the ear canal.

Here's an analysis of the provided text regarding acceptance criteria and the study demonstrating the device's performance:

Acceptance Criteria and Device Performance for Amplisound Quell 908TD (K132965)

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not explicitly state formal "acceptance criteria" against which the device was measured in a clinical study with specific thresholds for success. Instead, it demonstrates substantial equivalence to predicate devices through a comparison of technical characteristics and a statement that the device "performs similarly."

Therefore, the table below reflects the comparison points used for demonstrating substantial equivalence rather than explicit acceptance criteria. The reported device performance is drawn directly from the comparison table and surrounding text.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical study with human subjects. The document primarily refers to bench testing measurements using "actual ears" (presumably representative models or individual ears used for fitting) and "2cc ANSI tests in a test box." The number of "actual ears" or test box measurements is not specified.
• Data Provenance: The testing appears to be retrospective in nature, comparing the performance of the new device to existing predicate devices. It is conducted in a laboratory or bench setting rather than a multi-center clinical trial. The location of the testing is not explicitly stated but is implicitly associated with the manufacturer (Amplisound Hearing Products & Services, Danielson, CT, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not applicable as the document describes technical/bench testing, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" for these technical measurements would be the established scientific and engineering standards for sound output and frequency response in hearing devices.

4. Adjudication Method for the Test Set:

• This is not applicable as there was no "test set" requiring adjudication by human experts in the context of a clinical study. The performance was assessed via objective physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, a MRMC comparative effectiveness study was not done. This device is a sound generator for tinnitus, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• The study described is inherently a standalone performance evaluation of the device's physical and acoustic output characteristics (maximum output, frequency response, battery drain). It assesses the device's technical specifications without direct human user interaction being a primary measurement endpoint. The device's sound output is "algorithm-only" in the sense that it generates sound based on its internal digital processor, but it's a hardware device, not a software algorithm for analysis.

7. The Type of Ground Truth Used:

• The ground truth employed was based on objective physical measurements and established engineering standards for audiological devices (e.g., OSHA standards, ANSI test protocols). The comparison was made against the published specifications and performance characteristics of legally marketed predicate devices. The "white noise characteristic" (smooth response, less low-frequency emphasis, greater high-frequency emphasis) of the predicate devices served as a de facto "ground truth" for the desired acoustic output.

8. The Sample Size for the Training Set:

• This information is not applicable. The device is a hardware sound generator, and the submission describes its technical performance and equivalence to predicate devices, not a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable for the reasons stated in point 8.

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